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

Model Number	AA61121002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 burst and fell out during use.No other adverse patient effects were reported.
Additional Manufacturer Narrative
According to available information, this device burst and fell out during use.No other adverse patient effects were reported.According to the complaint description, lot number of intermediate product was known as 8546547.Intermediate product aa611280 with lot number 8546547 was used in only one finished product: aa61121002 lot number 8679872.Aa61121002 lot number 8679872 was manufactured in july 2022 for (b)(4) pieces.The expiry date is july 2027.This product was manufactured by our tunisian subcontractor, which was prevented on 29th november.Checking the quality databases did not reveal any anomaly in relation to the described defect and a corrective and preventive action is ongoing (b)(4) "balloon bursting trending for folysil and silicone prostatic catheters.".On 29th november we received investigation from our subcontractor.Inflating and leak testing for one hour was carried out in accordance with operation si121 and therefore the product was compliant.The probable causes of this defect are balloon material or the presence of air bubbles.On 4th january we received one used sample.Visually we saw that balloon was burst.The sample was sent to our subcontractor.On 25th january we received investigation with sample." balloon burst was probalby cause by a defect raw material.".In parallel, a specific trend is followed regarding the issue of the silicone balloon by the implementation of a capa (corrective and preventive action) tw470775 in order to remedy this issue.

• 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: 15928866
• Report Number: 9610711-2022-00108
• Device Sequence Number: 4459510
• Product Code: EZL
• UDI-Device Identifier: 03600040127247
• UDI-Public: 03600040127230
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: AA61121002
• Device Catalogue Number: AA6112
• Device Lot Number: 8679872
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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