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

Catalog Number 302100

Device Problem Volume Accuracy Problem (1675)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 syringe 1ml ls tuberculin had scale marking issues.The following information was provided by the initial reporter, translated from (b)(6): "some syringe memory is double printed.I don't think this can be measured accurately.".

Manufacturer Narrative

H.6.Investigation: four photos and forty-four (44) samples were received by our quality team for evaluation.From the photos, illegible scale line printing (printing overlap) was observed.Twenty-five of the returned samples did not belong to tuas manufacturing.The remaining nineteen samples were subjected to visual inspection and illegible scale line printing (printing overlap) 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 probable root cause of this nonconformance could be that the mandrel bearing was worn-out.This causes the mandrels rotation to not be smooth and create a jerky motion.The jerky mandrels with play cause the scale line on the printing pad being transferred twice when the mandrels move left and right, thereby overriding the scale on the barrel surface.

Event Description

It was reported syringe 1ml ls tuberculin had scale marking issues.The following information was provided by the initial reporter, translated from japanese: "some syringe memory is double printed.I don't think this can be measured accurately.".

• 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: 12378666
• MDR Text Key: 268510224
• Report Number: 8041187-2021-00777
• 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: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: 0157814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1