MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿ IV INSULIN SYRINGE

Catalog Number	329424
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle on a bd micro-fine¿ iv insulin syringe was barbed, causing damage to veins and there were a few people who developed abscesses after injection.It was also reported that the plunger on the syringe was stiff and difficult to move.There was no report of medical interventions.
Additional Manufacturer Narrative
Customer returned 100 1cc, 12.7mm, 28g insulin syringes in sealed blister packs with the shelf carton from lot # 7072881.Customer states that the needle is barbed, causing damage to the veins, causing abscesses, and the plunger is very stiff.Thirty out of 100 returned syringes were tested for point geometry, lube, and cannula od (specs: outer diameter for 28g: 0.0140¿-0.0145¿).All observations fall within specifications.All of these samples were also tested and the plunger rods were able to move without any observed defects.A review of the device history record was completed for batch # 7072881.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD MICRO-FINE¿ IV INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7370950
• Report Number: 1920898-2018-00163
• Device Sequence Number: 19221531
• Product Code: FMI
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 329424
• Device Lot Number: 7072881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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