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

Catalog Number 302100

Device Problem Melted (1385)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was received by our quality team for evaluation.From the photo, barrel tip damage was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The team investigated different sections of the syringe machine and matched a potential area which could lead to the reported defect.The syringe barrel tip 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 tip 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.A new air-jet will be fabricated to improve the auto-reject station to increase air flow and improve proper kick-out of the rejected parts.Communication with the production technicians to raise awareness on the reported defected will also occur.This incident has been added to our database of reported incidents.

Event Description

It was reported when using the syringe 1ml ls tuberculin the product was damaged/deformed - device was operable.The following information was provided by the initial reporter.The customer stated: "the surface of the syringe (hub) was melted.".

• Brand Name: SYRINGE 1ML LS TUBERCULIN
• 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: 12416285
• MDR Text Key: 271341075
• Report Number: 8041187-2021-00792
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: 0167927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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