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

Model Number	AA61101002
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot number.Checking the quality databases revealed that the balloon burst is known.We received a used catheter.After decontamination with anioxyde 1000, we observed the balloon burst.The balloon burst issue is known and monitored on a monthly basis.We don't know the root cause.Based on the above, this complaint confirmed as a product defect.No other corrective action will be implemented as the specific trend for balloon burst and this product family has an average during the last 12 month of 11ppm which is considered acceptable as per the threshold of 25ppm.
Event or Problem Description
According to the available information, a (b)(6) patient in charge for abdominal trauma during a rugby shock.Following the placement of a vesical catheter because of the presence of a vesical globe, the patient felt a pain along the penis.After checking the catheter , the nurse saw that there is a leak in the meatus and that there is no liquid in the balloon during the deflation.After withdrawal of the catheter , decided by the doctor , it turns out that the balloon burst.The bladder catheter had to be removed early caused pain for the patient and was ineffective.In addition, there is a risk of lesions of the urogenital ways.
Additional Manufacturer Narrative
This follow-up mdr is created to document the additional information received.
Event or Problem Description
Additional information received, stated that no pieces remained in the patient.Unclear if the liquid previously reported was urine or from the balloon.The patient was also suffering from a liver injury at the time of this incident.There was right kidney contusion polar reported.
Additional Manufacturer Narrative
This follow-up was created to document the correction of the results code.

• Brand Name: PED FOLYSIL CATH 3ML CH10/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6702949
• Report Number: 9610711-2017-00019
• Device Sequence Number: 13830161
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AA61101002
• Device Catalogue Number: AA61101002
• Device Lot Number: 5260838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 06/12/2017; 06/12/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/26/2019; 10/08/2019
• 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
• Patient Age: 13 YR