MAUDE Adverse Event Report: TELEFLEX MEDICAL BLADDER CATHETER, PVC, TIEMANN; CATHETER, UROLOGICAL

Model Number	IPN050977
Medical Device Problem Codes	Device Handling Problem (3265); Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: my brother has issue with his urethra and he have to go to doctor for catheterization every 2-3 weeks.He is bleeding after this procedure.They put the catheter in and instructing him to take it out in day or two.Then he needs to return used catheter back to doctor.My question for you is if you look at the pictures do the catheters originally from your factory looks like this with the cut outs.In our opinion these look like they have been cut out by someone at home? the edges are sharp rigged and also the space is too close and make the catheter too weak and collapsing and that in my opinion is causing the bleeding followed by swollen passage in urethra and necessity for repeated procedures.Please let me know if this is your unmodified product.I would like to bring this up to our urologist.No device available for investigation.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that: my brother has issue with his urethra and he have to go to doctor for catheterization every 2-3 weeks.He is bleeding after this procedure.They put the catheter in and instructing him to take it out in day or two.Then he needs to return used catheter back to doctor.My question for you is if you look at the pictures do the catheters originally from your factory looks like this with the cut outs.In our opinion these looks like they have been cut out by someone at home; the edges are sharp rigged and also the space is too close and make the catheter too weak and collapsing and that in my opinion is causing the bleeding followed by swollen passage in urethra and necessity for repeated procedures.Please let me know if this is your unmodified product.I would like to bring this up to our urologist.No device available for investigation.
Additional Manufacturer Narrative
(b)(4).No product was returned for investigation and the lot number is unknown, therefore a visual examination or a manufacturing document review could not be performed.The product was manufactured in 2014 (shelf-life is 5 years) and should not be used since at least 2020.The catheter eyes are manipulated, the existing eyes have been enlarged, are uneven and sharp-edged.Furthermore, an additional third catheter eye was cut out.However, the catheters are only manufactured with 2 catheter eyes.In addition, the customer reported that the catheter was placed by the doctor, the customer should remove it after 1-2 days and return it to the doctor.According to the ifu, the catheter is not suitable for long-term use and is also a single-use product.A manufacturing-related failure could not be identified.Possible root cause is an intentional use error.Based on the investigation above, we cannot confirm the complaint.

• Brand Name: BLADDER CATHETER, PVC, TIEMANN
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• Manufacturer (Section G): TELEFLEX MEDICAL; willy-rusch-str. 4 - 10; 71394 kernen 71394 ; GM 71394
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13584950
• Report Number: 9610520-2022-00002
• Device Sequence Number: 4642511
• Product Code: KOD
• UDI-Device Identifier: 04026704031870
• UDI-Public: 04026704031870
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: Health Professional
• Device Model Number: IPN050977
• Device Catalogue Number: 221800-000240
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown