MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; ANTISTICK SYRINGE

Catalog Number 305930

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 reported lot # unknown regarding item # 305930, the complaint could not be confirmed, and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.Unable to complete dhr check as the lot number is unknown.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd safetyglide¿ insulin syringe with attached needle caused a dirty needle stick to the nurse when their thumb slipped past the safety.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "increased number of nurse needle sticks that seem to have been with the safety glide syringes.".

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: ANTISTICK 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: 11467094
• MDR Text Key: 239729180
• Report Number: 1920898-2021-00286
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 305930
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• 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
• Patient Outcome(s): Other