MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10CC S/T WOS STERILE WATER BNS; PISTON SYRINGE

Catalog Number 304086

Device Problems Entrapment of Device (1212); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.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 a syringe 10cc s/t wos sterile water bns had plastic debris from the plunger that was found stuck or trapped in between the plunger and inner tip/wall of the barrel.The customer believes this caused a void or channel where water leaked post manufacturing.

Event Description

It was reported that a syringe 10cc s/t wos sterile water bns had plastic debris from the plunger that was found stuck or trapped in between the plunger and inner tip/wall of the barrel.The customer believes this caused a void or channel where water leaked post manufacturing.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The reported issue was previously investigated.It was concluded that the damage found in the barrel was caused due to improper setup of the silicone gun used to spray medical grade silicone inside the barrel.If the silicone gun is setup loose, it could contact and damage the barrel during processing.Situational analysis (b)(4) opened to evaluate the foreign matter issue associated with all complaints received so far and capa: 768379 was also initiated.

• Brand Name: SYRINGE 10CC S/T WOS STERILE WATER BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8359672
• MDR Text Key: 137141367
• Report Number: 1213809-2019-00264
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304086
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other