MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SHERLOCK 3CG* TCS SENSOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770131

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

During x-ray review showed the picc tip curled back on itself in the basilic vein.The sherlock 3cg demonstrated an elevated p wave with the tip followed to a green diamond ¿lollipop¿.The inserter reported no issues with insertion and flash back and flushed with ease.The cxr was taken directly post insertion this report is for second event of three reported.

• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 9685046
• MDR Text Key: 193969123
• Report Number: 3006260740-2020-00466
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741124341
• UDI-Public: (01)00801741124341
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770131
• 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: 01/08/2020
• 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