MAUDE Adverse Event Report: COVIDIEN 3570 KENGUARD SILCATH 5CC 24FR; CATHETER, UROLOGICAL

Model Number	3570
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Sweating (2444)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The patient reports that the suprapubic foley catheter was inserted on (b)(6) 2019 and stopped draining on the evening of (b)(6) 2019 at the patient's home.The patient stated that the catheter was not clogged, it just stopped draining completely after four days.The patient stated he has been a c5 quadriplegic for 34 years, and using the medtronic covidien brand foley catheter for at least ten years and changes them every 4 weeks.When using the catheter he does not realize there is a problem until his blood pressure (bp) goes up (180/95 to 210/110) and he starts sweating due to autonomic dysreflexia.He was able to have someone drain the balloon but only an insignificant amount of urine was able to be drained.His bp stayed high and someone applied nitro paste lowering the bp somewhat.After 1.5 hours, a nurse arrived and changed the catheter, about 24 oz of urine drained, and the crisis ended.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The actual sample was dissected, a blister was found inside the funnel area.This blister would block the flow of urine through the drainage lumen inside the funnel area, thus causing the non-drainage issue reported by the customer.The samples were manufactured before the implementation of a manufacturing corrective action that was put into place for this condition.The corrective action is taken to include additional workmanship and materials to improve the process and this has been determined to be effective.

• Brand Name: 3570 KENGUARD SILCATH 5CC 24FR
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): COVIDIEN; mediquip sdn.bhd. padang lati,; kangar, perlis ; MY
• MDR Report Key: 8898912
• Report Number: 9611712-2019-00100
• Device Sequence Number: 16551185
• Product Code: KOD
• UDI-Device Identifier: 10884521016743
• UDI-Public: 10884521016743
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: No Information
• Device Model Number: 3570
• Device Catalogue Number: 3570
• Device Lot Number: 8335K16QX
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 61