MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA; PISTON SYRINGE

Catalog Number	329424
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2019
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# 8127842.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failures as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issues are unconfirmed as no samples or photos were returned.
Event or Problem Description
The following was reported for syringe 1.0ml 28ga 1/2in bls 500 bdd ca, " it was reported that four needles had a split tip, one needle was unable to pass fluid when the plunger was depressed and there were others that were bent.Verbatim: tested 10 rigs from lot, found 5 damaged - 4 w/ split tip, 1 unable to pass fluid when plunger depressed.Another user stated they had quite a few damaged or bent - the one he had his shot in was so damaged, that i had to remove the plunger and turn the rig upside to get the drugs/liquid out, because nothing would come out of the needle tip.".
Additional Manufacturer Narrative
Investigation: customer returned (5) 1cc, 12.7mm, 28g bd insulin syringes with an open blister pack from lot # 8127842.Customer states that there is a split tip, they were unable to pass fluid, and they were bent.All returned syringes were examined and no bent cannula was observed.All samples also were examined under the microscope and 3 out of 5 samples exhibited an improper bevel on the cannula tip.All samples were also tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 8127842.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (improper bevel) unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (bent and clogged) as per manufacturing, probable root cause for the clog in the cannula is due to excessive silicone that dried in the tip of the cannula.
Event or Problem Description
The following was reported for syringe 1.0ml 28ga 1/2in bls 500 bdd ca, " it was reported that four needles had a split tip, one needle was unable to pass fluid when the plunger was depressed and there were others that were bent.Verbatim: tested 10 rigs from lot, found 5 damaged - 4 w/ split tip, 1 unable to pass fluid when plunger depressed.Another user stated they had quite a few damaged or bent - the one he had his shot in was so damaged, that i had to remove the plunger and turn the rig upside to get the drugs/liquid out, because nothing would come out of the needle tip.".

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8440452
• Report Number: 1920898-2019-00275
• Device Sequence Number: 303678
• Product Code: FMF
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 329424
• Device Lot Number: 8127842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/24/2019
• 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