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

Model Number	CK000539
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6750321
• Report Number: 3006260740-2017-01167
• Device Sequence Number: 1967724
• Product Code: LJS
• UDI-Device Identifier: 00801741105197
• UDI-Public: (01)00801741105197
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 117