MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6314
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
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.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 available information, this device was not able to be used due to a hair.There was a hair in the packaging before it was opened.
Event or Problem Description
According to the available information, a hair was found in the packaging on a folysil product.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot n°8710097.Checking the quality databases revealed no anomaly in connection with the described defect.There are 2 possible causes for hair in packaging: 1.Operators in the production didn't notice the hair on the catheter.There is a visual inspection in the process to detect this type of failure.The issue was not detected by this control.2.Recent investigations found that hair complaints can be traced back to the tunisian supplier we receive catheters with hair already on them.We trained the operators about this kind of failure and the importance of wearing hair net in the production.We also contacted the tunisian supplier regarding the hairs inside the packages in catheters.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17375851
• Report Number: 9610711-2023-00144
• Device Sequence Number: 7261177
• Product Code: EZL
• UDI-Device Identifier: 03600040128640
• UDI-Public: 3600040128640
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Catalogue Number: AA6314
• Device Lot Number: 8710097_AA63141002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown