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

Device Problems Difficult to Insert (1316); Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the temp sensing catheter stopped at the stricture upon insertion and allegedly caused self-limited bleeding.No medical intervention was reported.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.A labeling review cannot be completed due to no product catalog # provided.The drf label section will reflect adequate as the there is no "n/a option" and there is not enough information to determine the labeling to be inadequate.The device was not returned.

Event Description

It was reported that the temp sensing catheter stopped at the stricture upon insertion and allegedly caused self-limited bleeding.No medical intervention was reported.

Event Description

It was reported that the temp sensing catheter stopped at the stricture upon insertion and allegedly caused self-limited bleeding.No medical intervention was reported.

Manufacturer Narrative

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

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 temp sensing catheter stopped at the stricture upon insertion and allegedly caused self-limited bleeding.No medical intervention was reported.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8439342
• MDR Text Key: 139539396
• Report Number: 1018233-2019-01478
• 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: consumer,distributor,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2019

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 03/25/2019; 04/26/2019; 05/09/2019
• Supplement Dates FDA Received: 04/03/2019; 05/13/2019; 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1