MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE

Catalog Number 301029

Device Problem Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7118837, medical device expiration date: 04/30/2022, device manufacture date: 04/28/2017.Medical device lot #: 7178878, medical device expiration date: 06/30/2022, device manufacture date: 06/27/2017.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 before use, a bd syringe luer-lok¿ tip was found with wet, humidity embedded contamination.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Results: bd received samples for investigation.The syringes were found to have no visual defects.All ten syringes had small silicone droplets visible in the barrel.No stringing of silicone was observed.No pooling of silicone was observed.The amount observed was a normal and expected amount of silicone for this product per product specification.This observed perceived ¿moisture¿ is normal silicone content from the syringe.Assembly process: silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Dhr review for batch 7178878 (p/n 301029): manufacturing dates: 06/29/2017 ¿ 06/30/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Silicone weight tests were performed as per requirement during the manufacture of this batch with results within the acceptable range.Batch 7178878 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Conclusion: the investigation could not confirm the reported defect.Capa is not required as no defects were confirmed.

• Brand Name: BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7097393
• MDR Text Key: 94410463
• Report Number: 1213809-2017-00331
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301029
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other