MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER W/ SHERLOCK 3CG TIP POSITIONING SYSTEM, STYLET BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional 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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported via medwatch "ultrasound guidance was used to identify vein.Dynamic, real-time imaging of vessel cannulation performed.Sterile gel and probe cover used in ultrasound-guided central venous catheter insertion.Chloraprep antiseptic used during central venous catheter insertion.Skin prep agent completely dried prior to procedure.Hand hygiene performed prior to central venous.Cap, mask, sterile gown, sterile gloves and sterile drape used.Left basilic vein was located using ultrasound, needle was placed with blood return, guidewire was advanced 5-10 cm until there was resistance and so advancement was stopped and guidewire was pulled back along with the needle 2-3 cm until resistance was met and stopped.Attempted to remove needle and guidewire together but was unable to do so.Needle was easily removed over the guidewire.Procedure was aborted.With the guidewire remaining in place, pressure was applied to the site with minimal bleeding.Lidocaine was administered at site and patient was given iv morphine for pain control.Surgeons were notified, doctors all responded to bedside to evaluate patient.X-ray was completed.Decision was made to take patient to operating room for foreign body removal.Mom and patient were updated and all questions were answered." "picc placement was consulted for patient who required long term iv antibiotics.".

• Brand Name: POWERPICC SV CATHETER W/ SHERLOCK 3CG TIP POSITIONING SYSTEM, STYLET BASIC TRAY
• Common Device Name: 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17490728
• Report Number: 3006260740-2023-03412
• Device Sequence Number: 7253123
• Product Code: LJS
• UDI-Device Identifier: 00801741086915
• UDI-Public: (01)00801741086915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 1274118
• Device Lot Number: REHQ1792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Hispanic