MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F TL POWERPICC HF 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number CK000539

Device Problem Malposition of Device (2616)

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

Event Date 06/11/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaw0049 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported that picc was placed on (b)(6) 2017, in the right basilica vein.Placement was "uneventful", 5fr triple lumen picc, 38 cm long with 2 cm exposed.Picc placement verified with 3cg.Twelve days post placement nurse was informed that the picc "stopped working" and cathflo did not help.Picc was still 2 cm out.Chest x-ray was done to check for malpositioning.The reading was proximal svc.An x-ray of the arm was done to see if it was a good idea for the picc team to replace.A single view is obtained, centered over the mid and lateral right chest including the right arm.Picc line is seen, tip extending to the mid superior vena cava.There is a moderate loop in the medial bicep region with an 's' shaped curvature of approximately 4cm.This could account for an 8 cm discrepancy of length from the expected position.There is no kinking or catheter fragmentation.With the previous picc malposition in 12-24 hours after replacement, interventional radiology decided to place a new picc.

• Brand Name: 5F TL POWERPICC HF 3CG MB
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6750321
• MDR Text Key: 81507429
• Report Number: 3006260740-2017-01167
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741105197
• UDI-Public: (01)00801741105197
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/28/2017

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 Expiration Date: 07/28/2018
• Device Model Number: CK000539
• Device Catalogue Number: CK000539
• Device Lot Number: REAW0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2016
• 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 Age: 49 YR
• Patient Weight: 117