MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number 306424

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: undetermined.Rationale: no batch #/sample available.

Event Description

It was reported that unspecified bd¿ syringe had incorrect label information.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported that it was reported that the ndc number on the label is not correct and is causing issues when scanning.Event description per (b)(4) states, bd customer service rep transferred caller stating she is having issues with syringes and the ndc number listed on them.She stated the ndc number should have a different 4 digit code in the middle of each ( example ndc number (b)(4) customer rep that transferred caller provided item numbers 306513- 306545 stating the bd item number is the 4-digit code plus the last two digits.) because that determines the drug in each syringe.It is causing confusion when scanning the items.She provided lot number-3134965 sodium chloride 10ml flush lot number 3135338- heparin 5ml and 10ml flush syringes, she was not aware of the part numbers.Customer rep that transferred caller provided item number.Additional information received from customer states: as pharmacists, we have issues with the first two segments of an ndc containing the same information for totally different products.Here is the logic that is typically embedded in an ndc (from the fda website - https://www.Fda.Gov/drugs/drug-approvals-and-databases/national-drug-code-directory): each listed drug product is assigned a unique 10-digit, 3-segment number.This number, known as the ndc, identifies the labeler, product, and trade package size.The first segment, the labeler code, is assigned by the fda.A labeler is any firm that manufactures (including re-packers or re-labelers), or distributes (under its own name) the drug.The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug for a particular firm.Different formulations or different strengths of the same formulation should be assigned different product codes.This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes.Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code.The third segment, the package code, identifies package sizes and types.Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.Both the product and package codes are assigned by the firm.The ndc will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.The second segment of an ndc number should be the strength dosage form and formulation of a product.Given this logic, heparin 10 unit/ml, heparin 100 unit/ml and normal saline should not have the same second segment as they are totally different products.Because they have the same second segment, this is how they display in our looking glass software that we use for chemotherapy dispensing and scanning.Heparin is a high risk medication, and it is disconcerting that different concentrations are being grouped together due to ndcs.It looks like the order ndcs that were assigned to these flush products did differentiate the second segment and now they are all grouped together.My hope is that numbering logic could be switched back.We have also submitted this concern to (b)(4) as our facility believes that this is a patient safety issue.

Manufacturer Narrative

The following fields have been updated with additional information: describe event or problem: it was reported that bd posiflush¿ heparin lock flush syringe had incorrect label information.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that it was reported that the ndc number on the label is not correct and is causing issues when scanning.Event description per snow states, bd customer service rep transferred caller stating she is having issues with syringes and the ndc number listed on them.She stated the ndc number should have a different 4 digit code in the middle of each ( example ndc number 082090-3065-13, 082090-3065-45 customer rep that transferred caller provided item numbers 306513- 306545 stating the bd item number is the 4digit code plus the last two digits.) because that determines the drug in each syringe.It is causing confusion when scanning the items.She provided lot number-3134965 sodium chloride 10ml flush lot number 3135338- heparin 5ml and 10ml flush syringes, she was not aware of the part numbers.Customer rep that transferred caller provided item number.Additional information received from customer states: as pharmacists, we have issues with the first two segments of an ndc containing the same information for totally different products.Here is the logic that is typically embedded in an ndc (from the fda website - https://www.Fda.Gov/drugs/drug-approvals-and-databases/national-drug-code-directory): each listed drug product is assigned a unique 10-digit, 3-segment number.This number, known as the ndc, identifies the labeler, product, and trade package size.The first segment, the labeler code, is assigned by the fda.A labeler is any firm that manufactures (including re-packers or re-labelers), or distributes (under its own name) the drug.The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug for a particular firm.Different formulations or different strengths of the same formulation should be assigned different product codes.This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes.Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code.The third segment, the package code, identifies package sizes and types.Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.Both the product and package codes are assigned by the firm.The ndc will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.The second segment of an ndc number should be the strength dosage form and formulation of a product.Given this logic, heparin 10 unit/ml, heparin 100 unit/ml and normal saline should not have the same second segment as they are totally different products.Because they have the same second segment, this is how they display in our looking glass software that we use for chemotherapy dispensing and scanning.Heparin is a high risk medication, and it is disconcerting that different concentrations are being grouped together due to ndcs.It looks like the order ndcs that were assigned to these flush products did differentiate the second segment and now they are all grouped together.My hope is that numbering logic could be switched back.We have also submitted this concern to ismp as our facility believes that this is a patient safety issue.Medical device brand name: bd posiflush¿ heparin lock flush syringe.Medical device type: nzw.Common device name: heparin, vascular access flush.Medical device manufacturer: columbus.Medical device catalog #: 306424.Unique identifier (udi) #: (b)(4).Manufacturing location: columbus pma/510(k)#: k090680.

Event Description

It was reported that bd posiflush¿ heparin lock flush syringe had incorrect label information.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported that it was reported that the ndc number on the label is not correct and is causing issues when scanning.Event description per snow states, bd customer service rep transferred caller stating she is having issues with syringes and the ndc number listed on them.She stated the ndc number should have a different 4 digit code in the middle of each ( example ndc number 082090-3065-13, 082090-3065-45 customer rep that transferred caller provided item numbers 306513- 306545 stating the bd item number is the 4digit code plus the last two digits.) because that determines the drug in each syringe.It is causing confusion when scanning the items.She provided lot number-3134965 sodium chloride 10ml flush lot number 3135338- heparin 5ml and 10ml flush syringes, she was not aware of the part numbers.Customer rep that transferred caller provided item number.Additional information received from customer states: as pharmacists, we have issues with the first two segments of an ndc containing the same information for totally different products.Here is the logic that is typically embedded in an ndc (from the fda website - https://www.Fda.Gov/drugs/drug-approvals-and-databases/national-drug-code-directory): each listed drug product is assigned a unique 10-digit, 3-segment number.This number, known as the ndc, identifies the labeler, product, and trade package size.The first segment, the labeler code, is assigned by the fda.A labeler is any firm that manufactures (including re-packers or re-labelers), or distributes (under its own name) the drug.The second segment, the product code, identifies a specific strength, dosage form, and formulation of a drug for a particular firm.Different formulations or different strengths of the same formulation should be assigned different product codes.This means even if the same formulations of a drug product ultimately deliver different strengths of the active ingredient to the recipient, they should be assigned different product codes.Also, drug products that share the same formulation but have different product characteristics that clearly distinguish one drug product version from another can not share the same product code under the same labeler code.The third segment, the package code, identifies package sizes and types.Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging.Both the product and package codes are assigned by the firm.The ndc will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.The second segment of an ndc number should be the strength dosage form and formulation of a product.Given this logic, heparin 10 unit/ml, heparin 100 unit/ml and normal saline should not have the same second segment as they are totally different products.Because they have the same second segment, this is how they display in our looking glass software that we use for chemotherapy dispensing and scanning.Heparin is a high risk medication, and it is disconcerting that different concentrations are being grouped together due to ndcs.It looks like the order ndcs that were assigned to these flush products did differentiate the second segment and now they are all grouped together.My hope is that numbering logic could be switched back.We have also submitted this concern to ismp as our facility believes that this is a patient safety issue.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8654769
• MDR Text Key: 148469242
• Report Number: 2243072-2019-01041
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other