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

Model Number AA61141002

Device Problems Delivered as Unsterile Product (1421); Device Contamination With Biological Material (2908); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2015

Event Type  malfunction  

Manufacturer Narrative

The issue of foreign material contamination is a known risk.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the complaint received, a small black hair was found inside the sterile 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-canéda, 24206 ; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4957735
• MDR Text Key: 23322833
• Report Number: 9610711-2015-00021
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/05/2019
• Device Model Number: AA61141002
• Device Catalogue Number: AA61141002
• Device Lot Number: 4045967
• Other Device ID Number: 03600040127360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other