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

Model Number	8888514604
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10373368
• Report Number: 1282497-2020-09283
• Device Sequence Number: 14175277
• Product Code: KGZ
• UDI-Device Identifier: 00884521149161
• UDI-Public: 00884521149161
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 8888514604
• Device Catalogue Number: 8888514604
• Device Lot Number: 183270232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1