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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chest Pain (1776); Hemoptysis (1887); Foreign Body In Patient (2687)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv1522 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "guidewire after piccline insertion were forgotten in the patient.Deemed to be handling errors.Picc line was not x-rayed after insertion, sherlock navigation and fine p wave.Picc line works fine.After two months, the patient searches for symptoms such as coughing bloody mucus and chest pain.X ray shows the guidwire placed in the trace region.It is removed.Deemed to be operational.Nothing wrong with the product according to the clinic.Serious injury : tracea damage.".

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the guidewire was left within the patient was confirmed.It was reported that the guidewire was forgotten within the patient.A single photograph of a damaged guidewire was returned for evaluation.The wire was segmented into two pieces with the bendable distal tip detached from the wire.The outer coil wire on the detached distal tip was elongated and unraveled.The proximal segment contained one notable bend near the proximal end.It is unknown if the damage to the guidewire occurred during product use or during removal from the patient after it was discovered to have been left in the patient.The product instructions for use contain detailed instructions on the clinical procedure.The ifu instructs the user, ¿withdraw the dilator and guidewire, leaving the small sheath in place.¿ h3 other text : evaluation findings are in section h.11.

Event Description

It was reported "guidewire after piccline insertion were forgotten in the patient.Deemed to be handling errors.Picc line was not x-rayed after insertion, sherlock navigation and fine p wave.Picc line works fine.After two months, the patient searches for symptoms such as coughing bloody mucus and chest pain.X ray shows the guidwire placed in the trace region.It is removed.Deemed to be operational.Nothing wrong with the product according to the clinic.Serious injury : tracea damage.".

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15737051
• MDR Text Key: 303097247
• Report Number: 3006260740-2022-04303
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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 Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REFV1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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