MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

Catalog Number 301948

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/02/2019

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 the syringe s2 20ml 18ga 1-1/2in bd (b)(4) experienced four cases of an inability to contain medication.The following information was provided by the initial reporter: nurse found that tip of barrel damaged or bent after opening the unit package.

Event Description

It was reported that the syringe s2 20ml 18ga 1-1/2in bd china experienced four cases of an inability to contain medication.The following information was provided by the initial reporter: nurse found that tip of barrel damaged or bent after opening the unit package.

Manufacturer Narrative

Investigation: bd has been provided with a photo for catalog 301948 lot 1810254 to investigate for this record.Visual inspection of the returned picture presented the tip broken.The material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use.The assembling machines have an on-line detection system that inspects 100% of the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel.Based on this fact, the reported nonconformance was produced due to some blockage in the primary packaging machine feeder.Dhr showed no indication of the alleged defect.

• Brand Name: SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8541649
• MDR Text Key: 144451807
• Report Number: 3002682307-2019-00264
• Device Sequence Number: 1
• Product Code: FMF
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 301948
• Device Lot Number: 1810254
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other