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

Catalog Number	S1274108D2
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that multiple same lot numbers occluding within short time after placement.Using additional kits because of leaking lumens.No other information was provided.The customer reported multiple events however the exact number of events was not provided to bd vascular access devices field assurance.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that multiple same lot numbers occluding within short time after placement.Using additional kits because of leaking lumens.No other information was provided.The customer reported multiple events however the exact number of events was not provided to bd vascular access devices field assurance.
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 leaking lumens for a powerpicc is unconfirmed because the problem could not be reproduced.One 4 fr d/l powerpicc was returned for evaluation.An initial visual observation showed use residues throughout the returned device, and nothing remarkable was observed during initial visual observations.A functional test of infusing and pressurizing both lumens with water using a 12 ml syringe were successful, and no leaking was observed from either lumen.Both lumens were patent to infusion without any resistance.Because the device failure could not be reproduced, the complaint of leaking powerpicc lumens is unconfirmed.Possible contributing factors may include placement of the device in the patient¿s vasculature, causing an occlusion in the device.H3 other text : evaluation findings are in section h11.

• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16748278
• Report Number: 3006260740-2023-01354
• Device Sequence Number: 3429337
• Product Code: LJS
• UDI-Device Identifier: 00801741154843
• UDI-Public: (01)00801741154843
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 03/31/2024
• Device Catalogue Number: S1274108D2
• Device Lot Number: REGZ0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: 69 YR
• Patient Sex: Female