MAUDE Adverse Event Report: BD BD SAFETYGLIDE INJECTION NEEDLE 25G X 1 (0.5MM X 25MM)

Catalog Number 305916

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/08/2018

Event Type  Injury  

Event Description

Injected the pt with vaccine, withdrew needle from right deltoid, used thumb to activate safety, needle started to slide and then bent directly into and through my right thumb.There were 2 points of entry/exit.

• Brand Name: BD SAFETYGLIDE INJECTION NEEDLE 25G X 1 (0.5MM X 25MM)
• Type of Device: INJECTION NEEDLE
• Manufacturer (Section D): BD
• MDR Report Key: 7352185
• MDR Text Key: 102917716
• Report Number: MW5075964
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 305916
• Device Lot Number: 7026978
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CALCIUM; FOLIC ACID; FOLIC ACID; PROTONIX; SYNTHROID; ZOLOFT
• Patient Age: 34 YR
• Patient Weight: 68