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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON
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COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON Back to Search Results
Model Number AB63221002
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2021
Event Type  malfunction  
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 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 available information, this catheter fell off of the patient.It was noted that the balloon had burst and a replacement with a new catheter was completed.No adverse patient effects were reported.
 
Manufacturer Narrative
Visual examination revealed a slit on the balloon, possibly caused by a weak area in the silicone material.Review of production records did not reveal any anomalies during production.
 
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Brand Name
X-FLOW CATHETER
Type of Device
CATHETER, RETENTION TYPE, BALLOON
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
MDR Report Key11269416
MDR Text Key238310185
Report Number9610711-2021-00012
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040144442
UDI-Public03600040144442
Combination Product (y/n)N
PMA/PMN Number
K013172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAB63221002
Device Catalogue NumberAB6322
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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