MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH OTHER; CATHETER, UROLOGICAL

Model Number	3213182
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer states "over the past year he cannot rely on the funnel ridge to demarcate the coude tip because multiple catheters in every box he has ever used of this catheter he has found catheters where the funnel ridge and coude tip do not align.He said he doesn't even utilize the ridge on funnel as he mostly disregards the ridge on funnel since he has found so many that are off.He does feel this is a manufacturing defect.He said mostly they are 25 degrees off and more rarely max 90 degrees off.In the box he has was looking at now he pulled some out and said the ridge is 1/8 turned to the right or left compared to the tip and another 1/4 turned off and another 45 degrees off.On many of these that aren't aligned he also notes the funnel sometimes is "mashed" a bit - not a perfectly round sometimes "mashed in half" as they are tightly packed in boxes ( confirms boxes are intact/ not smashed) but even on some with perfectly round funnels the marker is stiff off.For harm reported he said he is not too sure if this defect could have caused him any harm as he doesn't rely on the ridge anymore for coude placement.He looks only at the the coude tip prior to insertion and doesn't even look at ridge to guide his placement after the coude tip goes in.He can feel it internally if it is not aligned and will turn it slightly to get it through." consumer states he had "no pain with this but not sure if this can irritate something internally contributing to the bleeding episodes he had with use of it as described" in a separate case.He was advised ot to use anymore catheters with defects.
Additional Manufacturer Narrative
A2: sex: male based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005778470.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot.One another complaint was received on batch 3a01846 (from the same customer), but reported issue is different ¿ (b)(4) (material too stiff).The batch record review indicates no discrepancies.Machine a097 is equipped by vision system.The key point for installation and setting vision system is to provide a control of all catheters with the focus on catheters failure: eyelet no punch.Hangnail left in eyelets.Position of connector indicator and bent tip of catheter vision system must reject every catheter with at least of one failure mentioned above.Validation of the position of tiemann indicator was in scope of ccr-01239.Ccr-01239 was signed on december 19th, 2019.Lot in question was produced after validation of the camera.A query was run against product gentlecath ic tiem ch16x405mm(1x100pk)us for malfunction code uca-pmc07.04 which yielded no other occurrence in past 12 months.The issue occurrence is considered as isolated for this type of product.No further action is required.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3005778470.

• Brand Name: GENTLECATH OTHER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18349542
• Report Number: 3005778470-2023-00365
• Device Sequence Number: 17484306
• Product Code: KOD
• UDI-Device Identifier: 00768455145546
• UDI-Public: 00768455145546
• Combination Product (Y/N): N
• PMA/510(K) Number: K172924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: Lay User/Patient
• Device Model Number: 3213182
• Device Lot Number: 3A01846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown