MAUDE Adverse Event Report: COVIDIEN 5146 PENROSE TUBE 1/4 IN; ACCESSORIES, CATHETER

Model Number 8888514604

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the product was falling apart when trying to use them.The issue was noticed almost immediately upon opening the packaging.There was no patient involved.

Manufacturer Narrative

Additional information: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Samples were not provided for evaluation.The failure mode could not be confirmed and the root cause and corrective actions could not be identified if samples are received at a later date, the complaint will be reopened for investigation.According to product validation, there is no expiration date for penrose family products, however actions have been issued to add the expiration date to the label artwork of penrose family products.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: 5146 PENROSE TUBE 1/4 IN
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10373368
• MDR Text Key: 202962561
• Report Number: 1282497-2020-09283
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00884521149161
• UDI-Public: 00884521149161
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: No Information
• Device Model Number: 8888514604
• Device Catalogue Number: 8888514604
• Device Lot Number: 183270232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 12/08/2020
• Patient Sequence Number: 1