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

Model Number 324912

Device Problem Defective Device (2588)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/27/2021

Event Type  malfunction  

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 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
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12537712
• MDR Text Key: 273569131
• Report Number: 1920898-2021-01018
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 0252919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1