MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 50ML LL PRECISE

Catalog Number 300144

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 50ml ll precise had foreign matter.The following information was provided by the initial reporter: brown stain in syringe.

Manufacturer Narrative

H6: investigation summary: one sample was received by our quality team for evaluation.From the sample, brown embedded foreign matter was observed on the inner wall of the syringe at two locations.The brown foreign matter was sent for microscope fourier transform infrared spectroscopy (ftir) testing to determine the foreign matter type.The ftir results show that the spectrum of foreign matter had no good match available in the library.The foreign matter showed some peaks that were similar to that of polypropylene, likely the base material of the syringe.This was likely because some of the base material was embedded in the foreign matter.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 cause of this embedded foreign matter could be a result of degraded polypropylene in an aging hydraulic press, cleaning of the injection screw of the molding machine.The hydraulic press has been replaced by an electrical press after this batch was produced.H3 other text : see h10.

Event Description

It was reported that syringe 50ml ll precise had foreign matter.The following information was provided by the initial reporter: brown stain in syringe.

• Brand Name: SYRINGE 50ML LL PRECISE
• Type of Device: 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: 12648220
• MDR Text Key: 276908122
• Report Number: 8041187-2021-00907
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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: 300144
• Device Lot Number: 1049923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• 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