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

Catalog Number 304086

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8057936, medical device expiration date: n/a, device manufacture date: 2018-02-26; medical device lot #: 8025585, medical device expiration date: n/a, device manufacture date: 2018-01-25.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 there was no water in the syringe 10cc s/t wos sterile water bns prior to use.

Manufacturer Narrative

Investigation: one 10ml syringe was received; however, since the reported issue was previously investigation, no further investigation is required.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number(s) that could have contributed to the reported defect.The reported issue was previously investigated.After exhaustive review of the assembly process, 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.

Event Description

It was reported that there was no water in the syringe 10cc s/t wos sterile water bns prior to use.

• 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: 8347805
• MDR Text Key: 136613494
• Report Number: 1213809-2019-00208
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 304086
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other