MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 20ML 21GA 1-1/2IN; SYRINGE WITH NEEDLE

Catalog Number 300330

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

(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 that breakage occurred with a syringe s2 20ml 21ga 1-1/2in.The following information was provided by the initial reporter, "this incident happened in cath lab while doing the stent procedure called percutaneous coronary intervention (pci).In it, a balloon tipped tube is inserted into an arety and moved to the point of blockage, when the balloon is inflated, the stent expands and they use bd discardit 20ml syringe along with normal saline to expand stent balloon at certain limit through creating pressure with syringe, in doing same they have to push and pull plugger many times to create pressure which lead to break off the tip of syringe.

Event Description

It was reported that breakage occurred with a syringe s2 20ml 21ga 1-1/2in.The following information was provided by the initial reporter, "this incident happened in cath lab while doing the stent procedure called percutaneous coronary intervention (pci).In it, a balloon tipped tube is inserted into an artery and moved to the point of blockage, when the balloon is inflated,the stent expands and they use bd discardit 20ml syringe along with normal saline to expand stent balloon at certain limit through creating pressure with syringe, in doing same they have to push and pull plugger many times to create pressure which lead to break off the tip of syringe.

Manufacturer Narrative

Investigation: bd has not been provided with photos or samples for catalog 300330 lot 1809504 to investigate for this record, unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Dhr showed no indication of the alleged defect.

• Brand Name: SYRINGE S2 20ML 21GA 1-1/2IN
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8558438
• MDR Text Key: 145636699
• Report Number: 3002682307-2019-00274
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903003303
• UDI-Public: 382903003303
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 300330
• Device Lot Number: 1809504
• Date Manufacturer Received: 04/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other