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

Device Problem Material Invagination (1336)

Patient Problems Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2022

Event Type  malfunction  

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 temperature-sensing foley catheter was removed from the patient who complained of discomfort and cuffing was observed on the photo sample, which caused discomfort during removal.Stated that 2 of the patients experienced discomfort.As per additional information received via email on 21oct2022, customer stated that they still continued to see risk connect entered that their patients were reporting painful removal of the foley, and a ring was identified at the tip of the catheter on removal.No medical intervention was reported.As per additional information received via email on 01nov2022, stated that there was a ring around the tip which was trauma or bleeding or pain to patients upon removal.They had 2 risk connects placed on (b)(6) 2022 previously for 2 intensive care unit patients.It was also stated that there was another report of a patient at that time, but this was not entered in risk connect.There were then 2 new risk connect entered that morning for 2 spine patients for (b)(6) 2022 with the same event.All patients had a procedure that event in the operating room and it was believed that those foley were placed intra-op.The foley was sequestered that morning and the lot number read lot# ngfy4396 and interestingly enough when they opened the new foley that day and compared the lot number from the outside of the box and what the foley said lot# ngfx4867 both had different lot numbers.

Event Description

It was reported that the temperature-sensing foley catheter was removed from the patient who complained of discomfort and cuffing was observed on the photo sample, which caused discomfort during removal.Stated that 2 of the patients experienced discomfort.Per additional information received via email on 21oct2022, customer stated that they still continued to see risk connect entered that their patients were reporting painful removal of the foley and a ring was identified at the tip of the catheter on removal.No medical intervention was reported.Per additional information received via email on 01nov2022, stated that there was a ring around the tip which was causing trauma, bleeding, and pain to patients upon removal.They had 2 risk connects placed on (b)(6) 2022 and (b)(6) 2022 previously for 2 intensive care unit patients.Stated that there was another report of a coi patient at that time, but this was not entered in risk connect.There were then 2 new risk connect entered that morning for 2 spine patients for (b)(6) 2022 with the same event.All patients had a procedure preceding that event in the operating room and it was believed that those foley were placed intra-op.The foley was sequestered that morning and the lot number read lot# ngfy4396 and when they opened the new foley that day and compared the lot number from the outside of the box and what the foley said lot# ngfx4867 both had different lot numbers.The outside of the box showed ngfx4867 and inside foley had a lot number of ngy4396.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.Although an exact root cause could not be determined a potential root cause could be balloon material does not shrink quickly enough.The lot number was unknown; therefore, the device history record could not be reviewed.Labelling review was not required as the product catalog number was unknown.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15788354
• MDR Text Key: 307591520
• Report Number: 1018233-2022-08733
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other