MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 3ML CH10/5; SILICONE FOLEY CATHETER

Model Number	AA61101002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without the benefit of evaluation and testing results, 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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, during a urinary catheter a first catheterization, catheter could not be placed because of the impossibility of remove the stylet.A second attempt to implant a catheter is carried out with another catheter same lot.This also failed, the stylet had to be forcibly removed.This second catheter was finally implemented successfully without stylet.No clinical consequences were reported.However this incident has caused an increase in time of the intervention: 1 hour instead of 15 minutes.An infectious risk existed at that.

• Brand Name: PED FOLYSIL CATH 3ML CH10/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5674110
• Report Number: 9610711-2016-00016
• Device Sequence Number: 18874614
• Product Code: EZL
• UDI-Device Identifier: 03600040127100
• UDI-Public: 03600040127100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2016

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
• Operator of Device: Health Professional
• Device Model Number: AA61101002
• Device Catalogue Number: AA61101002
• Device Lot Number: 4699255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2016
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO