MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE

Catalog Number 301942

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd¿ syringe needle pulled out of the hub during use and broke off in the patient's body.When removing the broken needle piece, the nurse was "stabbed" by it.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: "during the process of blood drawing, the needle fell off from the needle hub and broke in the patient's body.At present, the needle had been taken out, and the medical staff was stabbed when pulling out the needle." "when the nurse was removing the broken needle, nurse was injured by the needle.".

Event Description

It was reported that the bd¿ syringe needle pulled out of the hub during use and broke off in the patient's body.When removing the broken needle piece, the nurse was "stabbed" by it.This occurred on 2 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from chinese to english: "during the process of blood drawing, the needle fell off from the needle hub and broke in the patient's body.At present, the needle had been taken out, and the medical staff was stabbed when pulling out the needle." "when the nurse was removing the broken needle, nurse was injured by the needle.".

Manufacturer Narrative

H.6 investigation summary: bd has been provided with a sample for catalog 301942 lot 1811189 to investigate for this record.Visual examination of the sample revealed that there was no cannula fixed in the hub of the needle.As a result, bd was able to verify the reported issue.Bd concludes that this issue happened during the cannula assembly process because of some viscosity variation in the epoxy which results in some inappropriate epoxy dosage.Consequently, the epoxy was not applied to the correct position fixing incorrectly the needle.This is a very unusual circumstance because the needles are 100% inspected for presence of epoxy in the manufacturing process.Based on our investigation, we can conclude the root cause for this issue happened during the cannula assembly process, probably because of some viscosity variation in the epoxy what resulted in some inappropriately epoxy dosage.Therefore, the epoxy was not applied to the correct position fixing incorrectly the needle was with failure in the epoxy dosage which produced the incorrect fixing of the needle.The device history review showed no indication of the alleged defect.Considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no corrective actions are required at this time.H3 other text : see h.10.

• Brand Name: BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 9671502
• MDR Text Key: 188323628
• Report Number: 3002682307-2020-00033
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 301942
• Device Lot Number: 1811189
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other