MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 3ML LS; PISTON SYRINGE

Catalog Number 302106

Device Problem Leak/Splash (1354)

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

Event Date 09/28/2021

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 bd syringe 3ml ls failed to contain medication.The following information was provided by the initial reporter, translated from "when aspirating saline with bd's syringe.The hcp saw the solution leaking.The hcp then checked the product and found an about 3-cm crack on the barrel.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for evaluation?: yes.D.9.Returned to manufacturer on: 10/25/2021 h.6.Investigation: two photos and one sample were received by our quality team for evaluation.From the photos and the sample, the syringe barrel was observed to be bowed and cracked.The sample was subjected to barrel bow measurement and failed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The cracked barrel could be caused by poor feeding of the barrel which hit against the infeed dial pocket.This could have occurred at the molding machine, there is a bubbler tube which functioned to flow water for cooling the molded parts through the core pin.The probable root cause could be due to the bubbler tube choked and insufficient water supply to cooling the barrel resulting in a bowed barrel.

Event Description

It was reported bd syringe 3ml ls failed to contain medication.The following information was provided by the initial reporter, translated from "when aspirating saline with bd's syringe.The hcp saw the solution leaking.The hcp then checked the product and found an about 3-cm crack on the barrel.".

• Brand Name: BD SYRINGE 3ML LS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12703195
• MDR Text Key: 278580993
• Report Number: 8041187-2021-00930
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302106
• Device Lot Number: 0268096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• 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