MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 3CG TPS 4F FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number 2194108

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reew3047 showed no other similar product complaint(s) from this lot number.

Event Description

Vein laceration during insertion.Start date: (b)(6) 2021; end date: (b)(6) 2021.It was reported the event occurred at the right side of the body.Mild severity and unrelated to the device (catheter), but related to the procedure and unlikely related to accessories (guidewire, stylet).Outcome: recovered, no sequalae.No action taken.Additional details of adverse event were provided as: "vein laceration, due to needle displacement before guidewire was inserted.Hence picc inserted on 2nd attempt using tunnelization with the same kit, uneventfully.".

• Brand Name: POWERPICC SOLO 3CG TPS 4F FULL TRAY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11642665
• MDR Text Key: 245924940
• Report Number: 3006260740-2021-01248
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2194108
• Device Lot Number: REEW3047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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