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

Model Number	N/A
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer, iv consult came in to assess no blood return on a 3l picc.Caps were changed on all three lumens.However, blood reflux in the white lumen and cap.This was noted within minutes after changing the cap, pulsatile flushing with 10ml, clamping, and removing the syringe.This only occurred with the white lumen.The picc was placed 8.25.There were no other items that stood out that may have contributed to this fail, i.E.Kink in the or malfunction of the clamp.The device was removed from the patient.
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 complaint of bleed back is confirmed but the cause is unknown.One photograph of a 5 fr triple lumen powerpicc was returned for evaluation.An initial visual observation of the photograph showed that the white extension leg of the catheter appeared to have both red and clear liquid in the tube, proximal of the engaged clamp.No damage to the clamp or the catheter tubing was observed in the returned photograph.Although fluid was seen proximal of the engaged clamp, there were no distinguishing features in the photo which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer, iv consult came in to assess no blood return on a 3l picc.Caps were changed on all three lumens.However, blood reflux in the white lumen and cap.This was noted within minutes after changing the cap, pulsatile flushing with 10ml, clamping, and removing the syringe.This only occurred with the white lumen.The picc was placed 8.25.There were no other items that stood out that may have contributed to this fail, i.E.Kink in the or malfunction of the clamp.The device was removed from the patient.

• Brand Name: POWERPICC HF CATHETER WITH SHERLOCK 3CG TPS
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20484361
• Report Number: 3006260740-2024-06003
• Device Sequence Number: 19733164
• Product Code: LJS
• UDI-Device Identifier: 00801741101038
• UDI-Public: (01)00801741101038(11)240523(17)250930(10)REJR1454
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000509
• Device Lot Number: REJR1454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: Other
• Patient Sex: Unknown