MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, PROBE COVER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer, 4f dl picc kinked in arm couple days after being inserted.Additional info from customer: ((b)(6)2023): it was reported "soft tissue sacrococcygeal mass.This was an inpt.Left basilic vein was used.Picc was removed by the provider.Delay in iv medications.Picc had to be replaced and the left arm used.Delay in care.Patient had to endure another procedure.".
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.Based on a review of this information, the following was concluded: the complaint of a kink in the catheter was inconclusive due to the sample condition.A single radiographic image was returned for evaluation of this complaint.The image was of the arm and chest with an antecubital picc.Only the proximal end of the picc was visible in the image.From this view, it could not conclusively be determined if a kink was present in the catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer, 4f dl picc kinked in arm couple days after being inserted.Additional info from customer: ((b)(6) 2023): it was reported "soft tissue sacrococcygeal mass.This was an inpt.Left basilic vein was used.Picc was removed by the provider.Delay in iv medications.Picc had to be replaced and the left arm used.Delay in care.Patient had to endure another procedure.".

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, PROBE COVER)
• 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: 17358113
• Report Number: 3006260740-2023-03066
• Device Sequence Number: 6543903
• Product Code: LJS
• UDI-Device Identifier: 00801741154942
• UDI-Public: (01)00801741154942
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D3
• Device Lot Number: REHP2611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White