MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Catalog Number 309620

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ syringe catheter tip 2oz has been found experiencing 11 occurrences of mixed product/lots before use.The following has been provided by the initial reporter: it was reported that the customer had 11 cases of product and while picking item 309620 lot 9240840 which is labeled as a 50ml, the product was mixed with item no 309620 lot 9056659 which is labeled as a 60ml.Verbatim: customer called stating they have 11 cases of product and while picking item 309620 lot 9240840 which is labeled as a 50ml, the product was mixed with item no 309620 lot 9056659 which is labeled as a 60ml.

Event Description

It has been reported that the bd¿ syringe catheter tip 2oz has been found experiencing 11 occurrences of mixed product/lots before use.The following has been provided by the initial reporter: it was reported that the customer had 11cases of product and while picking item 309620 lot 9240840 which is labeled as a 50ml, the product was mixed with item no 309620 lot 9056659 which is labeled as a 60ml verbatim: customer called stating they have 11cases of product and while picking item 309620 lot 9240840 which is labeled as a 50ml, the product was mixed with item no 309620 lot 9056659 which is labeled as a 60ml.

Manufacturer Narrative

H.6.Investigation summary: eleven cubes were provided by the customer for investigation.The returned cubes were visually examined using unaided vision and were all found to be labeled as 50ml syringe catheter tip product.The change in scale mark from 60 ml to 50 ml was an intentional change, and not a non-conformance.Bd has made a business decision to move from 60 ml syringes to 50 ml syringes based on the following reasons: help drive safe sterile compounding practice by preventing overfill of medications and complying with aseptic technique.Standardize the bd® large volume syringe offering a better manage market supply and mitigate the risk of product shortages resulting from market related events.3.Align with other medication receptacles that may be in short supply (i.E.50 ml mini bags, 50% dextrose prefilled syringe, sodium bicarbonate prefilled syringe, ect.) to facilitate product substitution with no anticipated clinical impact.Prior to changing the product to 50 ml, notifications were sent to the customers about the upcoming change.The letter, which was dated (b)(6) 2019, specifies that 50 ml syringes could arrive at facilities between (b)(6) and (b)(6) 2019.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD¿ SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9324638
• MDR Text Key: 191112488
• Report Number: 1911916-2019-01209
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 309620
• Device Lot Number: 9056659
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other