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

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

Patient Problem Urinary Tract Infection (2120)

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 the patient arrived from an outside facility with a temp sensing foley in place and developed a uti (urinary tract infection) after the use of the catheter.The patient was placed on antibiotic, ceftriaxone.

Manufacturer Narrative

The reported event was inconclusive as no sample was 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 is not required.The product code for this z3002/b220 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient arrived from an outside facility with a temp sensing foley in place and developed a uti (urinary tract infection) after the use of the catheter.The patient was placed on antibiotic, ceftriaxone.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: UNKNOWN TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9648040
• MDR Text Key: 177020403
• Report Number: 1018233-2020-00636
• 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: 02/18/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention