MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SHERLOCK 3CG TCS; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number 9770131R

Device Problems Device Sensing Problem (2917); Data Problem (3196)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm, unit is not tracking correctly.

Manufacturer Narrative

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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of incorrect magnet tracking was unconfirmed.The tracking and ecg functioned correctly as received.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm, unit is not tracking correctly.

• Brand Name: REFURB, SHERLOCK 3CG TCS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10341062
• MDR Text Key: 201040119
• Report Number: 3006260740-2020-02702
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741125300
• UDI-Public: (01)00801741125300
• Combination Product (y/n): N
• PMA/PMN Number: K113808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770131R
• Device Catalogue Number: 9770131R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1