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

Model Number	AA61121002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the catheter balloon burst and then had to be replaced.
Additional Manufacturer Narrative
This follow-up was created to document the conclusion of the investigation.After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number.The expiry date is august 2024.Checking the quality databases revealed a corrective and preventive action.We received 13 sealed samples and 1 used with the balloon burst, aa61121002 lot number 7029773, after tested the balloons with air and osmosis water.The samples in a simulation bath from february 11 until february 25.At the end of the test, the result does not show any anomalies.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.

• Brand Name: SILIC FOLEY CATH 5/10ML /5
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9714302
• Report Number: 9610711-2020-00007
• Device Sequence Number: 19668394
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 03600040127230
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: AA61121002
• Device Catalogue Number: AA6112
• Device Lot Number: 7029773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other