MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD TUBERCULIN SYRINGE; PISTON SYRINGE

Catalog Number 302100

Device Problem Leak/Splash (1354)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one photo and one sample were received by our quality team for evaluation.From the photo, it was observed that the plunger rod detaches from the stopper and the plunger head is missing.From the returned sample, the plunger was observed to be separated from the stopper due to plunger head chip off.A device history record could not be evaluated as the lot number is unknown.The probable root cause of the plunger head chip off could have be due to the molded plunger tip hitting against the molded plunger target box when transferring from the molding machine to the assembly line.A curtain has been installed at the molded plunger target box in order to act as a cushion and reduce impulse.Communication with the production technicians to raise awareness of the reported defect will occur.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd¿ tuberculin syringe stopper separated from the plunger.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer uses this product for covid-19 vaccination.The customer reported that the stopper was separated from the plunger.".

• Brand Name: BD TUBERCULIN SYRINGE
• 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: 12508766
• MDR Text Key: 272695583
• Report Number: 8041187-2021-00853
• 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: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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