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

Model Number	AA61061002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Checking the quality databases revealed no anomaly in connection with the described defect.Unfortunately no sample is available from the customer and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.Based on the above this complaint is not confirmed.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 or Problem Description
According to the available information, the patient was very agile in his bed, so the catheter ruptured.Per hospital, no incident, because the catheter was broken above the branch of the catheter shaft - outside the body, and could be easily removed.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot number 6415063.Checking the quality databases revealed no anomaly in connection with the described defect.On june 6th we received 1 used and broken sample in 2 parts : 1 part at 18.5 cm ( body part ) and an other at the funnel we see some trace of glue of adhesive.We sent the sample to our subcontractor: no conclusive cause was determined; however re-sensitization of the operators was performed.

• 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: 8660650
• Report Number: 9610711-2019-00021
• Device Sequence Number: 2274634
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 6415063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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