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

Model Number	421568
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports unknown quantity from same lot that he "thinks had too much heat applied to the catheter itself during manufacturing causing catheter to stick to the packaging near tip causing a rough edge near/ on eyelets/tip making him bleed once and blue no touch sleeve sticking to packaging upon removal." he said it looks like the "machine that seals the catheters sealed it too hard and too much heat caused it to "melt the catheter tip to the packaging" and he has to physically "pop it out of place to move it up and out" from the packaging." he said the "melting at the tip also seemed to have caused a rough spot near/ on the eyelets on one of the catheters he used and he states it cut him in urethra.He said as he was inserting one he felt like something was pushing internally like a sharp piece near eyelets in his urethra.He said at one catheterization yesterday he noted a bit of bleeding in his drainage and a few remaining small clots he was able to pass.He said it only lasted for 1 or 2 caths and resolved itself, did not seek medical intervention.He did say he is on prescription blood thinner from a stoke he had in february of this year, name unknown.Bleeding resolved without intervention.He caths every 4 hrs for bladder dysfunction resulting from a previously enlarged prostate which was removed.He has catheterized with this catheters since (b)(6) 2021 and enjoys using this catheter and never had issues with them prior." this emdr covers the unknown number of catheters associated with rough edges for lot #2b03951.
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: (b)(4).Manufacturing site: (b)(4).
Additional Manufacturer Narrative
A batch record review was conducted resulting in the following: urinary catheter in question was packed under sap material id (b)(4), gentlecath glide male ch16 (1x30pk) us and manufacturing lot #2b03951 in c2 in march 2022 in amount 192,000 pcs on packaging machine p006.Parameters on machine was set up according to pi-001021 ver 3.0 for p006, gas paper 1731920.Process parameters were registered in form g905080.The used parameters were inspected and all were within validated range.Welding temperature, forming temperature, heating time, welding time and forming time were set up on nominal.During production of this lot, catheters were inspected according to g905704 v.18.0 process instruction for packaging gentle cath glide catheters on packaging machines p009/p006 and relevant inspection was recorded into the g905704 v.18.0 form 3.Visual inspection of catheters was performed according to: point 5.11.9.Sealed catheters - inspection of sealed catheters into the weld is a part of in-process control and carried out according to tm-437 test method for visual inspection of welding catheters in peelpack.No sealed catheters are allowed.Catheters were produced under subassembly lots 2b00665,2b03941,2c00318.All lots were assembled on machine a099.According to g805311 v 18 and 19 used during subassembly lots : point 5.12.4.- during in-process control catheters are taken according to iso 2859-1, il s4, aql 0,4 and inspected by an operator according to tm-356.Punched holes are not allowed if they have sharp edges, burrs, fibers, contain cuttings, cut-outs or punched holes are not smooth.Second operator perform inspection according to tm-356 too.Results of inspection are recorded in relevant forms (b)(4).Review of the dhr showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lot.No nonconformity was raised during sterilization process.Ifu packed with the product contains information do not use catheter if package has been damaged.No similar complaint was received on catheters part number 421568 and malfunction code (b)(4) catheter shaft, balloon, tip or eyelets too rough/jagged edges or too sharp within last 12 months.No samples or picture showing the defect were received.The issue occurrence is considered as isolated.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 GLIDE
• Common Device Name: CATHETER, URETHRAL
• 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: 15323053
• Report Number: 3005778470-2022-00056
• Device Sequence Number: 4667313
• Product Code: GBM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: K161348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 01/01/2025
• Device Model Number: 421568
• Device Lot Number: 2B03951
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male