MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 1.5ML CH06/5; SILICONE FOLEY CATHETER

Model Number	AA61061002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot number.On 12 july, we received a part of catheter with a burst balloon.The balloon burst issue is known and monitored on a monthly basis.Possible root cause is a weakness area in the silicone material of the balloon.No corrective action will be implemented as the specific trend for balloon burst of this product family has an average which is considered acceptable as per the threshold.
Event or Problem Description
According to the available information, the catheter was in the patient for 3 weeks (patient not mobile).Balloon has been deblocked once a week and then filled again with uromed 10% glycerin plus distilled water.In the 3rd week after deblocking balloon burst.No harm to the patient.

• Brand Name: PED FOLYSIL CATH 1.5ML CH06/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8856395
• Report Number: 9610711-2019-00027
• Device Sequence Number: 16718151
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: AA61061002
• Device Catalogue Number: AA6106
• Device Lot Number: 6540992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1