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

Model Number AA61141002

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/25/2015

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

There is a hair in the primary packaging.

• 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 caneda 24206, fr, ; FR
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5181306
• MDR Text Key: 30046351
• Report Number: 9610711-2015-00033
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 03600040127360
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: AA61141002
• Device Catalogue Number: AA61141002
• Device Lot Number: 4045967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1