MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 60CC LL TIP CONVENIENCE PAK; PISTON SYRINGE

Catalog Number 309680

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/16/2019

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 an unspecified number of syringe 60cc ll tip convenience pak experienced foreign matter contamination.The following information was provided by the initial reporter: material no.: 309680, batch no.: 8239985.Verbatim: excessive amounts of silicone on the plunger.

Event Description

It was reported that an unspecified number of syringe 60cc ll tip convenience pak experienced foreign matter contamination.The following information was provided by the initial reporter: material no.: 309680, batch no.: 8239985.Verbatim: excessive amounts of silicone on the plunger.

Manufacturer Narrative

Investigation: eleven (11) samples were provided by the customer for investigation.The samples were visually inspected using unaided vision and silicone was noted.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, however, some silicone may not be perfectly distributed.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Silicone readings are performed at the middle and end of each batch with all readings accepted; therefore, the condition reported by the customer cannot be confirmed.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: SYRINGE 60CC LL TIP CONVENIENCE PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8600364
• MDR Text Key: 145499168
• Report Number: 9610847-2019-00366
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096801
• UDI-Public: 30382903096801
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

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: 07/31/2023
• Device Catalogue Number: 309680
• Device Lot Number: 8239985
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/25/2019
• Supplement Dates FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other