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

Model Number	AA61201002
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to the information received from an end user, a nurse had inserted the catheter into the bladder of the patient.The balloon had been inflated with 8 ml saline solution.Few minutes after, the balloon had burst.The balloon appeared to be complete, after the catheter was removed and inspected, so no particles of the balloon remained in the bladder or in the urethra.The patient was not harmed, so a new catheter had been inserted.

• Brand Name: SILIC FOLEY CATH 5/15ML /5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6054151
• Report Number: 9610711-2016-00027
• Device Sequence Number: 1420406
• Product Code: EZL
• UDI-Device Identifier: 03600040127735
• UDI-Public: 03600040127735
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: Nurse
• Device Model Number: AA61201002
• Device Catalogue Number: AA61201002
• Device Lot Number: 5093101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR