MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/10ML /5; SILICONE FOLEY CATHETER

Model Number AA61141002

Device Problems Flushing Problem (1252); No Flow (2991)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Four samples were returned for evaluation - however, the evaluation has not been completed.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

The medical personnel of the complaining hospital has noticed on a (b)(6) male patient, urine could not flow through the catheter, which was inserted 3 hours ago.They have tried to improve/correct the position of the catheter under sonography, but without success.The catheter has been removed and inspected, even with a bladder syringe, the catheter could not be flushed.The foley catheter was placed in connection with a surgery in the visceral surgery theater.I spoke with the physician who has been asked for contribution during this surgery , because the patient had heart general problems.After replacement of the faulty catheter the patient suffered no more problems re urinary tract, he suffered no urosepsis (in his history he had 2 attacks of urosepsis).

• Brand Name: SILIC FOLEY CATH 5/10ML /5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-can[?]da, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold
• MDR Report Key: 6385777
• MDR Text Key: 69560520
• Report Number: 9610711-2017-00008
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 03600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K103174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA61141002
• Device Catalogue Number: AA61141002
• Device Lot Number: 5321758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR