MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/15ML /5; SILICONE FOLEY CATHETER

Model Number AA61181002

Device Problem Device Packaging Compromised (2916)

Patient Problem No Code Available (3191)

Event Date 08/25/2016

Event Type  Injury  

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

Emergencies room, patient went because of the liberal night nurse due to urinary catheter stuck.The catheter was put the morning by the urologist.In fact, the urinary catheter is no longer in the bladder, and during removal, there were only 5 ml into the balloon instead of 15.This problem has already occurred with a statement already made also by the same mrs (b)(6).Otherwise sterile packaging adheres to the packaging paper and forces them to use another catheter to perform a sterile care.No clinical consequences.

• Brand Name: SILIC FOLEY CATH 5/15ML /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,; service des réclamations; 9 avenue edmond rostand; sarlat la canéda cedex,, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5980066
• MDR Text Key: 55721458
• Report Number: 9610711-2016-00024
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AA61181002
• Device Catalogue Number: AA61181002
• Device Lot Number: 5187486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Date Manufacturer Received: 09/01/2016
• 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