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

Catalog Number 301948

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

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 when using the syringe s2 20ml 18ga 1-1/2in bd china the product was damaged/deformed - device is operable.The following information was provided by the initial reporter.The customer stated: "the nurse used a disposable sterile syringe (with needle) to fill the medicine for a child patient.After unpacking the device, she found the empty cylinder of the disposable sterile syringe in the bag was broken, she immediately replaced it.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided bd material 301948 and lot number 2012117.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples were obtained for evaluation by our quality engineer team.Through examination of the retained samples, no defects were identified.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported when using the syringe s2 20ml 18ga 1-1/2in bd china the product was damaged/deformed - device is operable.The following information was provided by the initial reporter.The customer stated: "the nurse used a disposable sterile syringe (with needle) to fill the medicine for a child patient.After unpacking the device, she found the empty cylinder of the disposable sterile syringe in the bag was broken, she immediately replaced it.".

• Brand Name: SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 12415448
• MDR Text Key: 273875984
• Report Number: 3002682307-2021-00457
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301948
• Device Lot Number: 2012117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1