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

Catalog Number 302100

Device Problem Material Separation (1562)

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

Event Date 08/05/2021

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 syringe 1ml ls tuberculin stopper had separated from the plunger.The following information was provided by the initial reporter, translated from japanese to english: "stopper separation from plunger ×1.".

Manufacturer Narrative

H.6.Investigation: six photos and three samples were received by our quality team for evaluation.From the photos, the plunger rod was observed to be detached from the stopper and the plunger head was missing, foreign matter was also observed inside the packaging.On the sample returned for the plunger separation issue, the team observed the plunger separation from the stopper due to plunger head chip off.The foreign matter was sent for ftir testing to determine the foreign matter type.The spectrum matches reasonably with poly (butyl acrylate) compound.This matches with brown tape used to join the bottom web syringe packaging.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.The probable root cause of plunger head chip off could have been due to the molded plunger tip hit against the molded plunger target box when transferring from the molding machine to assembly line.A curtain has been installed at the molded plunger target box to act as a cushion and reduce impulse after this batch was produced.The brown tape is used to join the bottom web together during changeover at the primary packaging station.The probable cause could be the production technician prepared the tape upfront, before joining the bottom web.If the tape is left unused for some time, the adhesive layer could be dried off.Then, when the production technician pastes the tape onto the bottom web, the brown tape is not fully adhered on the bottom web, which resulted in it to tangle and stick onto the top forming die during processing.The piece of brown tape was eventually sealed and packaged together with the product.However, this was not detected, and the part has been shipped out.H3 other text : see h.10.

Event Description

It was reported that the syringe 1ml ls tuberculin stopper had separated from the plunger.The following information was provided by the initial reporter, translated from japanese to english: "stopper separation from plunger ×1".

• 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: 12418186
• MDR Text Key: 271342386
• Report Number: 8041187-2021-00795
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302100
• Device Lot Number: 0324287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1