MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA63181002
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 separation.The tip separated from the device when it was opened.No other adverse patient effects were reported.
Additional Manufacturer Narrative
We have been informed about a damaged catheter on a folysil product.The review of the complaint history database, revealed no trends for the lot number 9041495.Checking the quality database revealed one change control cc tw (b)(4) "packaging - addition of longitudinal precuts" opened on (b)(6) 2013 and closed on (b)(6) 2014.On 21th june we received sealed samples.Sample were tested with dynamometer.One used sample received: after observation we note the tip was tore inside the inner packaging opened with transversal precut.The root cause is due to a use error.In addition, we have already had similar complaints received on the same issue, root cause identified at that time was that customers used the transversal pre-cuts available on the inner pouch and pinched the distal end of the catheters during opening of the packaging.Consequently, the distal end of the catheters broke before use or are damaged.Since implantation of change control tw 108129, it is strongly recommended to use longitudinal precuts.Transversal precut is not recommended and should be used with great caution.We assume the incidents described as catheter tip detachment noticed following insertion, probably initiated during opening the peel pouch using the transversal precut while pinching the tip, is a known issue observed in different references of the folysil catheters.Therefore, since 2013, a longitudinal precut has been added on the inner peel pouch (b)(6) to limit such incident.In the current case, the information provided by the complainant is limited regarding the way of opening of the peel pouch, and the incriminated device is not available for analysis.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 17090426
• Report Number: 9610711-2023-00116
• Device Sequence Number: 19534430
• Product Code: EZL
• UDI-Device Identifier: 03600040128909
• UDI-Public: 03600040128909
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: AA63181002
• Device Catalogue Number: AA6318
• Device Lot Number: 9041495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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