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

Catalog Number UNKNOWN

Device Problems Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

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 temperature 1 was not working on arctic sun device.The user had changed the foley, but the device was still not working.User mentioned that they do have a borrowed device.Mss asked if they had any more temperature cables or if they could borrow for which they replied that they did not.Per follow up via nurse on (b)(6) 2021, representative looked at the device and the 2 bard foley were observed faulty so they put a 3rd foley in and had no further issues.

Event Description

It was reported that temperature 1 was not working on arctic sun device.The user had changed the foley, but the device was still not working.User mentioned that they do have a borrowed device.Mss asked if they had any more temperature cables or if they could borrow for which they replied that they did not.Per follow up via nurse on 26mar2021, representative looked at the device and the 2 bard foley were observed faulty so they put a 3rd foley in and had no further issues.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause was not chosen due to a lack of information.It is unknown whether the device had met relevant specifications.It was unknown whether the product was used for treatment or diagnostics purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.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 latex temperature sensing catheter ifus are found to be adequate based on past reviews.The device was not returned.

• Brand Name: UNKNOWN LATEX TEMP-SENSING CATHETER
• Type of Device: UNKNOWN LATEX TEMP-SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11719216
• MDR Text Key: 247216736
• Report Number: 1018233-2021-02358
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other