MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 300912

Device Problem Material Integrity Problem (2978)

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

Event Date 12/12/2018

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 #: 8123909, medical device expiration date: 2023-04-30, device manufacture date: 2018-05-03.Medical device lot #: 8213972, medical device expiration date: 2023-07-31, device manufacture date: 2018-08-01.(b)(6).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 with the use of the bd syringe luer-lok¿ tip there was an issue with oily film in the interior of the syringe.

Manufacturer Narrative

Investigation summary: two sealed and one opened 10ml syringe blister packages were received and confirmed to be from batch # 8123909 (p/n 300912).One syringe in an open blister package was received from batch #8213972 (p/n 300912).All of the samples were visually inspected.The stoppers and barrel roofs of all 4 syringes were observed to have a small amount of silicone presence.The observed amount of silicone was normal and expected amount for this product per product specification.No defects were observed.A device history record review showed no rejected inspections or quality issues during the production of the two provided lot number that could have contributed to the reported defect.Please note that 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.Root cause not defined since defects were not confirmed in samples received.

Event Description

It was reported with the use of the bd syringe luer-lok¿ tip there was an issue with oily film in the interior of the syringe.

• Brand Name: BD SYRINGE LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8203067
• MDR Text Key: 131703717
• Report Number: 1213809-2018-00943
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903009122
• UDI-Public: 30382903009122
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• 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: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300912
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other