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

Model Number	421568
Medical Device Problem Codes	Unsealed Device Packaging (1444); Difficult to Remove (1528)
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.(b)(4).
Event or Problem Description
End user states "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 also mentioned when he was able to get these catheters unstuck to use, after busting water sachet, he said the blue no touch sleeve was stuck to the packaging and not going with the catheter when he went to remove it.One of the catheters that had this defect wasn't sealed well because when he went to pop the sterile packet it exploded right out of the packaging and wetness got all over him.".
Additional Manufacturer Narrative
A batch record review was conducted resulting in the following: urinary catheter in question was manufactured under sap material id 1713715, 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 and g906995.Burst test, bubble test, width of peel pack weld and visual inspection of catheters was performed according to: point 5.11.1.Burst test ¿ the bursting pressure must be greater as the lower limit of tolerance.Point 5.11.2.Tightness test - air bubbles cannot escape the peel pack within 10 seconds of testing time.Point 5.11.4.Width of weld - the weld must be at least 3 mm.Wide.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.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.No samples or picture showing the defect were received to above mentioned complaint.No other complaint of this nature, unsealed package, was received the last 12 months.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: 15323797
• Report Number: 3005778470-2022-00057
• Device Sequence Number: 5284273
• 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: 11/10/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/15/2022
• 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