MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 10ML 21GA 1-1/2IN

Catalog Number 301947

Device Problem Leak/Splash (1354)

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

Event Date 08/28/2021

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 that the syringe s2 10ml 21ga 1-1/2in experienced a damaged tip of syringe.The following information was provided by the initial reporter: opened the syringe and found the tip of barrel was broken.

Event Description

It was reported that the syringe s2 10ml 21ga 1-1/2in experienced a damaged tip of syringe.The following information was provided by the initial reporter: opened the syringe and found the tip of barrel was broken.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 2104196.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 of the same lot number were obtained for further evaluation.The retained samples were examined and no defects related to tip breakage or any syringe component breakage were identified.The complaint could not be confirmed and the root cause is undetermined.

• Brand Name: SYRINGE S2 10ML 21GA 1-1/2IN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12617288
• MDR Text Key: 276163859
• Report Number: 3002682307-2021-00546
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301947
• Device Lot Number: 2104196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1