MAUDE Adverse Event Report: COVIDIEN DOVER PREMIUM URINE METER FOLEY TRAY; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Catalog Number P4P16XTSD

Device Problems Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 09/11/2020

Event Type  malfunction  

Event Description

(b)(6) medical center csu & cvor leadership have been tracking issues with the covidien urine meter foley catheters for the last few weeks.The catheter itself is coming apart at the point of insertion with the reservoir bag even though the seal appears to be intact.The nursing staff in the cvor received the directive to lightly check for compromise prior to insertion and also to track the lot numbers of the foley catheters being checked and inserted.Manufacturer reference number (b)(4) lot # 20063396664 and 2007024864 have been problematic.10 occurrences were recorded.We believe this is creating an increase in the number of hospital acquired infections.Cardinal health sales rep (b)(4) notified.Fda safety report id# (b)(4).

• Brand Name: DOVER PREMIUM URINE METER FOLEY TRAY
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 10540590
• MDR Text Key: 207384084
• Report Number: MW5096660
• Device Sequence Number: 7
• Product Code: FFG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/11/2020
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: P4P16XTSD
• Device Lot Number: 2007024864
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other