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

Model Number	3570-
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); High Blood Pressure/ Hypertension (1908)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a catheter inserted on (b)(6) 2021 seemed to be draining poorly causing periodic hyperreflexia (sweating, pulsing headache).The catheter was removed and replaced on (b)(6) 2021.Additional information received on 26-mar-2021 stated that he did not take any medication to treat the issues while using the catheter.On (b)(6) 2021 his blood pressure was 191/99 during a spike (ad = autonomic dysreflexia) with a pulse of 42, but was normal ten minutes later (106/73 pulse 72).Additional information received on 30-mar-2021 stated that the catheter was inserted by a health professional and was not tested prior to use because it needed to remain sterile.This catheter drained after being removed.He stated that the catheter was either draining intermittently since it drains now, or there was a problem with his bladder that has since subsided.
Additional Manufacturer Narrative
The device history record was reviewed.The lot was released meeting all the acceptance criteria.The sample was received for evaluation.During investigation, the sample was subjected to an inflation test whereby 10ml water had been used as recommended in the specification.According to the investigation result, the balloon could be inflated as its intended use.The sample was also tested for proper drainage while the balloon was still inflated.Water flowed out normally through the eye.The inflated catheter was left overnight and then tested again for its drainage.Water was able to flow normally without obstruction through the eye.No indication of poor drainage can be observed.The reported condition was not able to be replicated and the assumption that a blocked drainage issue might cause the reported adverse event on the user was not able to be confirmed.At this time, no corrective and preventative action is deemed required.This complaint will be used for tracking and trending purposes.

• 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: 11661124
• Report Number: 9611712-2021-00107
• Device Sequence Number: 3072883
• Product Code: KOD
• UDI-Device Identifier: 20884521016740
• UDI-Public: 20884521016740
• 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): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 3570-
• Device Catalogue Number: 3570-
• Device Lot Number: 0169K16QX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1