MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978); Temperature Problem (3022)

Patient Problems Pain (1994); Anxiety (2328); Discomfort (2330); Alteration In Body Temperature (2682)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the intrepid patient's temperature increased from 37.9c to 38.2c during therapy on the arctic sun device.Therapy had been re-initiated after replacing a set of large pads with a medium set.The nurse stated that she believed the pads were replaced because they were too large and overlapped on the patient.Per troubleshooting with ms&s, the nurse was walked through connecting the pads, temp in and temp out cables, and restarting therapy.The nurse did not want to pre-warm the pads.She chose 'continue current patient' from the patient therapy selection screen.The patient temperature was 37.9c, water temperature was 19c, and flow rate was 2.9l/min.A bair hugger was placed per protocol.After 30 minutes, the nurse stated that the patient's temperature had increased to 38.2c and the water temperature had dropped to 10c.There were no signs of shivering, and causes of heat generation were discussed.Ms&s recommended she follow their drug protocol for fever control.The nurse stated that the md had just administered morphine.Additional information was later received via email on (b)(6) 2018, from cra (b)(6), that the set of large pads were removed on (b)(6) 2018 and therapy discontinued because the patient became agitated with cold.On (b)(6) 2018, when deciding to reapply pads, a set of medium pads were applied to the patient, as the large pads had overlapped previously on the back.The medium pads were removed due to discomfort from the foley catheter, allegedly causing agitation and restlessness.She stated that the patient lifted himself off the bed, pulled against the restraints, kicked off the bair hugger, and shouted to "pee pee." there were no complaints of cold pads on (b)(6) 2018.A bladder ultrasound was done, showing that the bladder was not overly full.Between nursing and md, it was determined that the patient was in pain and agitated due to the foley catheter.A dosage of ativan had been administered to the patient on (b)(6) 2018 at 11:14 with no effect.The patient became more agitated, shouting that he needed to "pee pee." morphine 1mg was then ordered and given at 12:02 on (b)(6) 2018.The patient settled and a condom catheter was applied.

Event Description

It was reported that the intrepid patient's temperature increased from 37.9c to 38.2c during therapy on the arctic sun device.Therapy had been re-initiated after replacing a set of large pads with a medium set.The nurse stated that she believed the pads were replaced because they were too large and overlapped on the patient.Per troubleshooting with ms&s, the nurse was walked through connecting the pads, temp in and temp out cables, and restarting therapy.The nurse did not want to pre-warm the pads.She chose 'continue current patient' from the patient therapy selection screen.The patient temperature was 37.9c, water temperature was 19c, and flow rate was 2.9l/min.A bair hugger was placed per protocol.After 30 minutes, the nurse stated that the patient's temperature had increased to 38.2c and the water temperature had dropped to 10c.There were no signs of shivering, and causes of heat generation were discussed.Ms&s recommended she follow their drug protocol for fever control.The nurse stated that the md had just administered morphine.Additional information was later received via email on 1(b)(6)2018 , from cra christine, that the set of large pads were removed on (b)(6)2018 and therapy discontinued because the patient became agitated with cold.On(b)(6)2018 , when deciding to reapply pads, a set of medium pads were applied to the patient, as the large pads had overlapped previously on the back.The medium pads were removed due to discomfort from the foley catheter, allegedly causing agitation and restlessness.She stated that the patient lifted himself off the bed, pulled against the restraints, kicked off the bair hugger, and shouted to "pee pee." there were no complaints of cold pads on (b)(6)2018.A bladder ultrasound was done, showing that the bladder was not overly full.Between nursing and md, it was determined that the patient was in pain and agitated due to the foley catheter.A dosage of ativan had been administered to the patient on (b)(6)2018 at 11:14 with no effect.The patient became more agitated, shouting that he needed to "pee pee." morphine 1mg was then ordered and given at 12:02 on (b)(6)2018.The patient settled and a condom catheter was applied.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.Corrections: concomitant medical products and device evaluated by mfr.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8228638
• MDR Text Key: 132485092
• Report Number: 1018233-2019-00155
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 76