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

Catalog Number 302100

Device Problem Failure to Deliver (2338)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: six photos and eight samples were received by our quality team for evaluation.From the photos, the team observed a damaged barrel and illegible scale marking, the team was not able to determine the functional failure on the plunger movement difficult.Six samples were received for plunger movement difficult, and two samples were returned for damaged barrel and scale marking issue.The samples returned for the damaged barrel issue were observed with damage at the barrel body which caused the printing rub off.The samples returned for the plunger movement difficult were subjected to the plunger breakout and sustaining force test and were within specification.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.As the samples passed the plunger breakout and sustaining force testing, a root cause was not able to be determined.For the barrel damage, the team investigated different sections of the syringe machine and matched a potential area which could lead to the reported defect.The syringe barrel damage could have occurred at the assembly machine.At the syringe assembly process, there is an auto-reject station where the rejected syringe will be removed.The probable root cause of barrel damaged could be due to the defect sample 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 was stuck at the assembly dial.The damage on the barrel caused the printing rub off.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 defects.This incident has been added to our database of reported incidents.

Event Description

It was reported when using the syringe 1ml ls tuberculin there was difficult plunger movement.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the "plunger was hard to move.".

• 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: 12539562
• MDR Text Key: 273543533
• Report Number: 8041187-2021-00867
• 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: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: 0268093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• 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