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

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.The device has not been returned, at this time, to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not yet been returned for evaluation.

Event Description

Per tm the sherlock (b)(4) is showing the picc coming in from the opposite side they are working from in addition to dropping off the screen.No other information was provided.

Manufacturer Narrative

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 inaccurate magnet tracking was unconfirmed.The magnet tracking and ecg readings were correct as received.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to refurbished inventory.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm the sherlock (b)(4) is showing the picc coming in from the opposite side they are working from in addition to dropping off the screen.No other information was provided.

• 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: 7308230
• MDR Text Key: 101478210
• Report Number: 3006260740-2018-00321
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741124341
• UDI-Public: (01)00801741124341
• 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: 08/30/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770131
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1