MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 1ML TUBERCULIN SYRINGE SLIP TIP

Catalog Number 302100

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 07/21/2021

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 that the bd 1ml tuberculin syringe slip tip experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: the customer uses this product for covid-19 vaccination.Damaged barrel: the barrel was bent and swelling.Leakage: when the hcp drew the solution with the syringe, leakage was observed.

Event Description

It was reported that the bd 1ml tuberculin syringe slip tip experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: the customer uses this product for covid-19 vaccination.(1) damaged barrel: the barrel was bent and swelling.(2) leakage: when the hcp drew the solution with the syringe, leakage was observed.

Manufacturer Narrative

H6: investigation summary : three photos and one sample were received by our quality team for evaluation.From the photos, barrel damage was observed.The sample was subjected to visual inspection and barrel damaged that caused leakage 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 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.The damage on the barrel caused the leakage.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.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD 1ML TUBERCULIN SYRINGE SLIP TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12340502
• MDR Text Key: 267245991
• Report Number: 8041187-2021-00744
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: 0161864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1