MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 'SYRINGE VET 3ML LL W/NDL 22X1 RB

Catalog Number 305661

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 04/04/2019

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 'syringe vet 3ml ll w/ndl 22x1 rb experienced needle breakage.The following information was provided by the initial reporter: material no.: 305661 batch no.: 9024827.Per (b)(4) verbatim: 1 incident occurred as they were drawing blood from a cat then the cat jerked its leg causing the needle to go through its leg, bend, and break off from the hub of the syringe.The technician was stuck by the needle.The technician underwent testing and received a tetanus shot, but no issues.They had to take the cat in for a xray and surgery to remove the needle.

Manufacturer Narrative

Investigation: one loose 3ml syringe with a detached needle was received and evaluated.It was observed the needle was bent at a 90-degree angle and broken off from the hub at the base.It appeared there was some dried red fluid on the needle and in the syringe.The defects were reported to happed during use and cannot be confirmed as a manufacturing issue.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Root cause not defined since defects were not confirmed in sample received.No corrective actions recommended since product defect was not confirmed.

Event Description

It was reported that the 'syringe vet 3ml ll w/ndl 22x1 rb experienced needle breakage.The following information was provided by the initial reporter: material no.: 305661, batch no.: 9024827.Per (b)(4) verbatim: 1 incident occurred as they were drawing blood form a cat then the cat jerked its leg causing the needle to go through its leg, bend, and break off from the hub of the syringe.The technician was stuck by the needle.The technician underwent testing and received a tetanus shot, but no issues.The y had to take the cat in for a xray and surgery to remove the needle.

• Brand Name: 'SYRINGE VET 3ML LL W/NDL 22X1 RB
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8557255
• MDR Text Key: 143374506
• Report Number: 1213809-2019-00479
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 305661
• Device Lot Number: 9024827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other