MAUDE Adverse Event Report: TELEFLEX MEDICAL FOLEY CATHETERS

Model Number	IPN054400
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that 3 catheters he tried have very sharp eyes.He is afraid to use any more of these.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
Customer reports that 3 catheters he tried have very sharp eyes.He is afraid to use any more of these.
Additional Manufacturer Narrative
(b)(4).To summarize, the reported catheter difficult to use, sharp eye, as follows: an investigation was initiated.The batch records were reviewed resulting in no discrepancies being indicated.All relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.Samples were received and tested.All samples met specification.We will continue to monitor complaints for additional occurrences of these issues and take appropriate action as required.

• Brand Name: FOLEY CATHETERS
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14375549
• Report Number: 3011137372-2022-00083
• Device Sequence Number: 17303212
• Product Code: KOD
• UDI-Device Identifier: 44026704619175
• UDI-Public: 44026704619175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K896729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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 Model Number: IPN054400
• Device Catalogue Number: 238500140
• Device Lot Number: 1729441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 07/08/2022
• 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: Male