MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH M; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number 1295108

Device Problems Entrapment of Device (1212); Uncoiled (1659)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

On (b)(6) 2016- per sales representative, user facility reported that upon insertion of the picc line the guidewire got caught in the tissue and came uncoiled.It was stated that the tip of the guidewire was lodged in the subcutaneous tissue and was removed in interventional radiology.There was no patient harm.The rn stated that she did not think it was a quality issue but a difficult tissue and anatomy issue.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F NURSE FULL TRAY WITH M
• Type of Device: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5769067
• MDR Text Key: 48752600
• Report Number: 3006260740-2016-00315
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034596
• UDI-Public: (01)00801741034596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1295108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR