MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG; SYRINGE, ANTISTICK

Catalog Number 305930

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples (including photos) were returned for the reported issue of "needle stick injury" with an unknown lot number, the complaint could not be confirmed, and the root cause is undetermined.A dhr check was not performed as the lot number is "unknown" for this complaint.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.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 investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported syringe 1.0ml 29ga 1/2in bls 400 sg had a safety mechanism failure.The following information was provided by the initial reporter: "a160202 - no fail-safe mechanism".

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG
• Type of Device: SYRINGE, ANTISTICK
• 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: 12329157
• MDR Text Key: 266878304
• Report Number: 1920898-2021-00896
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305930
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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