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

Catalog Number 302995

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/15/2019

Event Type  malfunction  

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 foreign matter occurred with a bd syringe luer-lok¿ tip.The following information was provided by the initial reporter, "material no.: 302995, batch no.: 9046704.It was reported that there were droplets of residue on the rubber stopper inside the syringe barrel.Per complaint form: customer noticed droplets of residue on the rubber stopper inside the syringe barrel.Droplets occur on the outside.These were noticed on 10ml syringes (4-5 times) as noted above, and 20ml syringes product code 302830 (4-5 times) but lot number was unavailable for 20ml syringes.Customer reported when products were left out to show as examples to other staff, the droplets seemed to dry out after some time.Customer has never seen this before and was a little concerned if this affected sterility of product.".

Manufacturer Narrative

Investigation: open packages and loose 10ml syringes were received: 9 from batch #9046704 and 3 from batch #9024735 (p/n 302995), as well as 3 open packages of 5ml batch #9015947 (p/n 309646).They were visually evaluated.11 of the 10ml syringes were observed to have small amount of visible silicone residue on the stopper and inside barrel roof area.The amount observed was normal and expected amount for the product per product specification.One 10ml syringe was observed to have excessive amount of silicone present on the stopper.One 5ml syringe was found to have a normal and expected amount of silicone per product specification.Two 5ml syringe were found to have a clearly excessive amount of silicone per specification.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.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.Potential root cause for the excessive silicone defect is associated with the assembly process.

Event Description

It was reported that foreign matter occurred with a bd syringe luer-lok¿ tip.The following information was provided by the initial reporter, "material no.: 302995, batch no.: 9046704.It was reported that there were droplets of residue on the rubber stopper inside the syringe barrel.Per complaint form: customer noticed dropplets of residue on the rubber stopper inside the syringe barrel.Dropplets occur on the outside.These were noticed on 10ml syringes (4-5 times) as noted above, and 20ml syringes product code 302830 (4-5 times) but lot number was unavailable for 20ml syringes.Customer reported when products were left out to show as examples to other staff, the droplets seemed to dry out after some time.Customer has never seen this before and was a little concerned if this affected sterility of product.".

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8601040
• MDR Text Key: 145650086
• Report Number: 1213809-2019-00523
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 302995
• Device Lot Number: 9046704
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other