MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE TEMP-SENSING CATHETER; TEMPERATURE SENSING FOLEY CATHETER

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that a (b)(6) year-old female patient developed sepsis during use of a temperature sensing foley catheter.The patient was admitted to the neurocritical care unit for left basal ganglia intracerebral hemorrhage with intraventricular extension and hydrocephalus.The patient was concurrently receiving targeted temperature management (ttm) therapy as part of the fever prevention arm of the intrepid study, which started on (b)(6) 2019.According to the clinical research assistant, the catheter had been in place for 14 days.The patient had leukocytosis with the following lab results: sputum culture, gram negative rods; urine culture, e-coli; blood cultures times two, e-coli with extended spectrum beta lactamase (esbl).The patient was treated per hospital protocol with a course of antibiotics.Zosyn was started on (b)(6) 2019.The patient was switched to ciprofloxacin on (b)(6) 2019 and then to unasyn on (b)(6) 2019.The patient completed ttm therapy on (b)(6) 2020 and comfort measures only care was implemented.The patient expired on (b)(6) 2020.The cause of death documented in the medical record was cardiopulmonary failure.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿materials of construction are not biocompatible¿ with a potential root cause of "materials of construction are not biocompatible".The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not required.The product code for this product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the silicone temperature sensing catheter product labeling is found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.

Event Description

It was reported that a 56-year-old female patient developed sepsis during use of a temperature sensing foley catheter.The patient was admitted to the neurocritical care unit for left basal ganglia intracerebral hemorrhage with intraventricular extension and hydrocephalus.The patient was concurrently receiving targeted temperature management (ttm) therapy as part of the fever prevention arm of the intrepid study, which started on (b)(6) 2019.According to the clinical research assistant, the catheter had been in place for 14 days.The patient had leukocytosis with the following lab results: sputum culture, gram negative rods; urine culture, e-coli; blood cultures times two, e-coli with extended spectrum beta lactamase (esbl).The patient was treated per hospital protocol with a course of antibiotics.Zosyn was started on (b)(6) 2019.The patient was switched to ciprofloxacin on (b)(6) 2019 and then to unasyn on (b)(6) 2019.The patient completed ttm therapy on (b)(6) 2020 and comfort measures only care was implemented.The patient expired on (b)(6) 2020.The cause of death documented in the medical record was cardiopulmonary failure.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9728900
• MDR Text Key: 188651615
• Report Number: 1018233-2020-01148
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 90