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

Catalog Number	329416
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary : no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 7241532.All inspections were performed per the applicable operations qc specifications.Investigation conclusion : bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description : root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale : based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that during use of the bd ultra-fine¿ insulin syringe the plunger rod is hard to move.
Additional Manufacturer Narrative
Investigation summary: customer returned (12) 1cc, 8mm, 31g syringes (2 loose, 10 in a sealed poly bag) from lot # 7241532.Customer states that they are having a hard time pressing the plunger and there are burrs on the needles.All returned syringes were tested and all were able to draw and expel properly without any observed defects.All returned syringes were also tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications.A review of the device history record was completed for batch# 7241532.All inspections were performed per the applicable operations qc specifications.There were three (3) notifications [200712892, 200712495, 200712933] noted that did not pertain 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.
Event or Problem Description
It was reported that during use of the bd ultra-fine¿ insulin syringe the plunger rod is hard to move.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8089925
• Report Number: 1920898-2018-00875
• Device Sequence Number: 2025397
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Catalogue Number: 329416
• Device Lot Number: 7241532
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/04/2018
• 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