MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM 10BAG 500CS; PISTON SYRINGE

Model Number	324912
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/27/2021
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.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.Based on the above, no additional investigation and no capa/sa is required at this time.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 6mm 10bag 500cs scale markings were misaligned.The following information was provided by the initial reporter: it was reported that insulin syringes has the needle shield off the syringe in bag.Caused a clean needle stick to employee that was treated with minor first aid.Verbatim: minor first aid was given to our employee.This was the first incident reporting of this employee.We have had four bags with insulin syringes that had at least one cap off in the plastic bag.(these are in our sharps container.) we have come across some insulin syringes that the caps are off in the plastic bag exposing the needle.This is a safety issue as we had an employee puncture his thumb which is then a biohazard.

• Brand Name: SYRINGE 1.0ML 31GA 6MM 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12537712
• Report Number: 1920898-2021-01018
• Device Sequence Number: 1335398
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2025
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 0252919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1