MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. INTERMITTENT CATHETER

Catalog Number MEDICAL UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Received from fda via (b)(4).Patient was on the toilet, and as she was cleaning her perineal area following a bowel movement, she expelled what appears to be a small intermittent catheter introducer tip.It is felt that the introducer tip disconnected from catheter kit when straight catheter procedure attempted with inadvertent access to the vagina rather than urethral meatus.

Manufacturer Narrative

(b)(4).The correct fda uf/importer report number is (b)(4).

• Brand Name: INTERMITTENT CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 10905836
• MDR Text Key: 218954350
• Report Number: 3011137372-2020-00270
• Device Sequence Number: 1
• Product Code: PNC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MEDICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1