MAUDE Adverse Event Report: BECTON DICKINSON HEPARIN 100UL 5ML FILL IN 10ML SYRINGE

Catalog Number	306513
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.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).
Event or Problem Description
It was reported that an unspecified number of heparin 100ul 5ml fill in 10ml syringe experienced incorrect label information.The following information was provided by the initial reporter: material no: 306513, batch no: unknown.Event description per states, customer service rep transferred caller stating she is having issues with syringes and the number listed on them.She stated the 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 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.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.
Event or Problem Description
It was reported that an unspecified number of heparin 100ul 5ml fill in 10ml syringe experienced incorrect label information.The following information was provided by the initial reporter: material no: 306513.Batch no: unknown.Event description per states, customer service rep transferred caller stating she is having issues with syringes and the number listed on them.She stated the 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 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.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.
Additional Manufacturer Narrative
H.6.Investigation: no photo or sample of item 306513 was provided for investigation.As no lot information was available, a device history review could not be performed.The complaint could not be confirmed and the root cause not determined.

• Brand Name: HEPARIN 100UL 5ML FILL IN 10ML SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8668812
• Report Number: 2243072-2019-01101
• Device Sequence Number: 263609
• Product Code: FMF
• UDI-Device Identifier: 00382903065134
• UDI-Public: 00382903065134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 306513
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other