MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP; SYRINGE, PISTON

Model Number 1183500777

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: syringes were found with debris and fiber inside, and on the plunger.Syringe also had a blue color inside.

Manufacturer Narrative

Initial lot number 1903202464 reported was actually unknown as the customer combined lots.

• Brand Name: 35ML SYRINGE LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11702291
• MDR Text Key: 262895714
• Report Number: 1915484-2021-01235
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010826
• UDI-Public: 10884521010826
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Device Lot Number: 1917644564
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2021
• Patient Sequence Number: 1