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

Catalog Number 9770131

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Picc nurse reported that during one picc placed on monday (b)(6) 2018 and three piccs placed on wednesday (b)(6) 2018 the piccs were placed about 5cm too short due to the pwave appearing too soon.All 4 picc placements were malpositioned too short.The nurse reported that he gets cxr with every procedure because he does not trust the 3cg technology.Using 3cg with vision ii ultrasound.

• Brand Name: SHERLOCK 3CG TCS SENSOR
• 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
• Manufacturer (Section G): QUALITEL CORP; 4608 150th ave ne; redmond WA 98052
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7987284
• MDR Text Key: 124668049
• Report Number: 3006260740-2018-02980
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741124341
• UDI-Public: (01)00801741124341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770131
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1