MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML; PISTON SYRINGE

Model Number 302995

Device Problem Fungus in Device Environment (2316)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported that prior to using a bd luer-lok¿ syringe sterile, single use, 10 ml , that mold was found on the syringe.The following information was provided by the initial reporter: the customer stated that there was visible mold in the sterile syringe, which rendered it useless.

Manufacturer Narrative

Additional email address: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Additional email address: (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 that prior to using a bd luer-lok¿ syringe sterile, single use, 10 ml , that mold was found on the syringe.The following information was provided by the initial reporter: the customer stated that there was visible mold in the sterile syringe, which rendered it useless.

Manufacturer Narrative

H.6.Investigation: two photos of 10ml luer-lok syringes (p/n 302995) in unopened packages were received and evaluated.In one photo a grey, grease like substance is seen inside the package.In the second photo a small amount of foreign matter could be seen just above the syringe in line with the stopper.The observed condition was non-conforming per product specification.Potential root cause for the foreign matter defect is associated with the packaging process.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that prior to using a bd luer-lok¿ syringe sterile, single use, 10 ml , that mold was found on the syringe.The following information was provided by the initial reporter: the customer stated that there was visible mold in the sterile syringe, which rendered it useless.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 10 ML
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13580723
• MDR Text Key: 286019984
• Report Number: 1213809-2022-00091
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

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 Model Number: 302995
• Device Catalogue Number: 302995
• Device Lot Number: 1288786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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