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

Model Number	510690
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age: 87.D2a common device name: catheter, urethral.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 "while trying to take the catheter out, the catheter tore a hole in the bottom of the package.Catheter was sealed to the bottom of the catheter package." this emdr covers the unknown number of catheters affected.
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 of this nature has been registered during the manufacturing process of the mentioned lot.The batch record review indicates no discrepancies.Based on the complaint issue reported the catheter was welded with the spot weld.This issue was observed several times in production area too, therefore the issue was submitted to r&d department as the product in question is new product.To avoid welding the sleeve with spot weld r&d set up the spot weld on nominal on (b)(6), 2022.The set up was recorded in logbook.The lot in question was produced before the set up in question.We have received one another complaint with malfunction code uca-pmc11.07 primary pack has incomplete or open seal / weld, or is torn, ripped damaged, split, cracked or crushed or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging since the beginning of gcafm production ¿ (b)(4)(gc cath protective sheath was welded).No harm was reported with this complaint.Based on above the complaint issue is considered as very 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 AIR
• 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: 16918050
• Report Number: 3005778470-2023-00106
• Device Sequence Number: 20513320
• Product Code: GBM
• UDI-Device Identifier: 00768455196272
• UDI-Public: 00768455196272
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/19/2023

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: 510690
• Device Lot Number: 2H03554
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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