MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 2ML 24GA 1IN

Catalog Number 300068

Device Problem Positioning Problem (3009)

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

Event Date 03/26/2019

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 300 syringe s2 2ml 24ga 1in experienced difficult plunger movement.The following information was provided by the initial reporter: there is a complaint on discardit 2ml with 24g needle that the syringe is of poor quality and also syringe is hard in use.We have got 3000 qty return from customers, so please investigate the issue on priority.I have personally spoken to 5-7 customers and they find ref no 300068 (mfg in (b)(4)) is difficult to use.

Manufacturer Narrative

Investigation: bd has been provided with 3 affected samples for catalog 300068 lot 1707503 to investigate for this record.After the analysis of the samples, the high sliding force to glide the plunger rod was apparent, verifying the reported issue.The reported functionality defect is produced by improper injection in the barrel filling phase.It could occur cause if there is a particle inside the mold that produces stripes in the internal wall of the barrel.In extreme cases, that issue could produce functionality problems during the use of the syringe.Dhr showed no indication of the alleged defect.

Event Description

It was reported that 300 syringe s2 2ml 24ga 1in experienced difficult plunger movement.The following information was provided by the initial reporter: there is a complaint on discardit 2ml with 24g needle that the syringe is of poor quality and also syringe is hard in use.We have got 3000 qty return from customers, so please investigate the issue on priority.I have personally spoken to 5-7 customers and they find ref no (b)(4) (mfg in fraga) is difficult to use.

• Brand Name: SYRINGE S2 2ML 24GA 1IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8500468
• MDR Text Key: 145535889
• Report Number: 3002682307-2019-00242
• 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,other,user facility
• 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: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 300068
• Device Lot Number: 1707503
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other