MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 23 X 1; SYRINGE, PISTON

Model Number 26547

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

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

The customer reported, the luer tip of the device was detached inside the package.

Manufacturer Narrative

The device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected.There were no nonconformance reports (ncr) related to this lot.There were no samples submitted with this complaint, however, a picture was sent by the customer and was analyzed.The needle hub looked to be fractured into 2 pieces.The reported condition is confirmed based on the customer provided image.The exact root cause of the reported condition could not be determined without a physical sample to examine.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT 3ML COMBO 23 X 1
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9608625
• MDR Text Key: 177374095
• Report Number: 1017768-2020-00776
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479201054
• UDI-Public: 10612479201054
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26547
• Device Catalogue Number: 26547
• Device Lot Number: 920367
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Patient Sequence Number: 1