MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LS TUBERCULIN; PISTON SYRINGE

Catalog Number 302100

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

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported syringe 1ml ls tuberculin had a damaged barrel.The following information was provided by the initial reporter, translated from (b)(6): "around 1 to 3 ml of the tip of the cylinder is swollen and deformed on the right side.".

Event Description

It was reported syringe 1ml ls tuberculin had a damaged barrel.The following information was provided by the initial reporter, translated from japanese: "around 1 to 3 ml of the tip of the cylinder is swollen and deformed on the right side.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/17/2021.H.6.Investigation: two photos and one sample were received by our quality team for evaluation.From the photos and sample, barrel damage was observed.A device history record could not be evaluated as the lot number is unknown.The syringe barrel damage could have occurred at the assembly machine.At the assembly process, there is an auto-reject station where the rejected syringe will be removed.The probable root cause of the damaged barrel could be due to the not being kicked out at the auto-reject station effectively.The syringe tip could have dislodged from the dial pocket and hit against the guide skirt; however, the barrel flange was stuck at the assembly dial.

• Brand Name: SYRINGE 1ML LS TUBERCULIN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12333994
• MDR Text Key: 267070245
• Report Number: 8041187-2021-00732
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1