MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD¿ 50 ML LS SYRINGE

Catalog Number 300143

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

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

Event Date 09/23/2021

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¿ 50 ml ls syringe experienced foreign matter in the barrel.The following information was provided by the initial reporter: a yellow foreign matter was found inside the barrel wall when the package was opened.

Manufacturer Narrative

Investigation summary: two photos were received by our quality team for evaluation.From the photos, foreign matter was observed on the barrel.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 no samples were returned to determine the foreign matter type, the root cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the bd¿ 50 ml ls syringe experienced foreign matter in the barrel.The following information was provided by the initial reporter: a yellow foreign matter was found inside the barrel wall when the package was opened.

• Brand Name: BD¿ 50 ML LS SYRINGE
• 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: 12675007
• MDR Text Key: 277722084
• Report Number: 8041187-2021-00917
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 300143
• Device Lot Number: 9025715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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