MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH AIR; CATHETER, URETHRAL

Model Number	510692
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported the end user "caths 6 x a day for retention from bladder atony, is not new to cic.Uses gc glide catheters typically and they work very well for him but he orders gcafm for their portability to use when he is out of his home.He started using cgafm about 6 months ago and has trialed various different sizes of this product and he overall prefers the 18 fr as it drains faster for him.He said he cannot be 100% certain but thinks this occured with some from each these 2 boxes and he is aware they are different refs and different ref sizes.He said this occurred to him about 4 times when he was out of his home and he had to use the catheter to drain his bladder with it as that was all he had.He said after he burst the water sachet to prep the catheter like usual, he opened the catheter to get it out.He said it was "fused to the bottom of the bag." he said he had to pull it out so hard he was concerned to rip the tubing of the catheter, however it did not.He said it was "very distressing" and had to use a catheter he had touched prior to use in order to get it out of the packaging, as he always avoids touching the catheter to avoid utis.He was concerned about developing a uti but said thankfully he did not develop a uti after using these.He adds that where the heat seal circle on the bottom half of the packaging "it looks crinkled" and thinks maybe the heat migrated down to the bottom and possibly that is what caused this to occur.He said as well that he bottom of the packaging should be square but these are "crinkled upwards." he stores them in a room temperature environment in his office.The mu boxes did not look damaged in any way.".
Additional Manufacturer Narrative
According to process instruction, all products must be inserted to the bag according to drawing 60132, point 5.15.4 weld - bag welds must be uniform along the entire length, without damage or any deficiencies, point 5.15.5 spot weld - spot welds of bag have to be uniform along the entire perimeter.All products are visually inspected by operators according this points - 100% visual inspection.Final inspection was also carried out by qa assistant on 125 samples and no discrepancy was found.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 of this nature has been registered during the manufacturing process of the mentioned lot.No another complaint has been received to lot#3a02654 and malfunction code "uca-pmc11.16 difficult to remove catheter from primary pack during use".The batch record review indicates no discrepancies.Based on the investigation, the issue is considered isolated.No additional action is required, and this complaint will be closed.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.

• Brand Name: GENTLECATH AIR
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce, 07101 ; LO 07101
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 22020159
• Report Number: 3005778470-2025-00540
• Device Sequence Number: 9484952
• Product Code: GBM
• UDI-Device Identifier: 00768455196333
• UDI-Public: 00768455196333
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K213283
• 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): 04/22/2025

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 Expiration Date: 12/01/2025
• Device Model Number: 510692
• Device Lot Number: 3A02654
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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 Age: 67 YR
• Patient Sex: Male