MAUDE Adverse Event Report: COVIDIEN P400 PREM U/M 16FR SL TMP CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number P4P16XTSD

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 that they have had an occurrence of tray leaking.The catheter is easily disconnected from the tubing at the green seal.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Two unused samples were received for the evaluation.Based on the procedure, a visual inspection was conducted on the received samples.Upon evaluation, the reported issue was not observed.In addition, a pull test was performed to the received samples, and the test meet the quality specifications.However, there have been complaints reported in the past for catheter detachment.As part of continuous improvements, a corrective action (capa) has been opened to address the reported issue.The results of investigation will be documented through the referred capa.

• Brand Name: P400 PREM U/M 16FR SL TMP CSD
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10871573
• MDR Text Key: 217335753
• Report Number: 9612030-2020-02698
• Device Sequence Number: 1
• Product Code: FFG
• UDI-Device Identifier: 10884521066984
• UDI-Public: 10884521066984
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P4P16XTSD
• Device Catalogue Number: P4P16XTSD
• Device Lot Number: 2006339664
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1