MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

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

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recu2720 showed no other similar product complaint(s) from this lot number.Device not received.

Event Description

The following was reported via an email sent to vad sales rep: "inability to aspirate blood with picc insertion despite picc at the cavoatrial junction (many repositioning ¿ mechanically irritating the vessel wall).Last week a coworker placed a picc, no blood return, in good position; that patient went to ir for picc in other arm.Line was exchanged in ir, currently looking for report".

• Brand Name: POWERPICC SOLO CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: heather murphy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225738
• MDR Report Key: 7972076
• MDR Text Key: 123955457
• Report Number: 3006260740-2018-02909
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741028090
• UDI-Public: (01)00801741028090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3295118
• Device Lot Number: RECU2720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• 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