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

Model Number AA61121002

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

According to the information received, the tip detached from the catheter while the patient was hospitalised.This happened at the intensive care unit - so the patient should have been under intensive care.Most likely, the loss of the catheter tip was detected after the catheter was removed, during catheter change.During the procedure of catheter change, the tip was removed from the bladder before the new catheter was inserted.Possibly caused by the patient by unintentional pull of the catheter.The tip could be removed from the bladder by surgical intervention on (b)(6) 2015 within the same procedure.The patient was not harmed.

• Brand Name: SILIC FOLEY CATH 5/10ML /5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la caneda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5304337
• MDR Text Key: 34357829
• Report Number: 9610711-2015-00038
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 03600040127230
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 12/16/2015

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: AA61121002
• Device Catalogue Number: AA61121002
• Device Lot Number: 4309325
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other