MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG); 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	07/22/2023
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that the introducer would not advance.When it was removed and inspected, a notch was noted where the inner and outer introducer segments join.The customer states this is the second time this has happened.Additional information received: it was stated the events directly affected patients, had to find alternate introducer.The event did not involve an urgent/life threatening medical situation, routine insertion.This report addresses the first event.
Event or Problem Description
It was reported by customer that the introducer would not advance.When it was removed and inspected, a notch was noted where the inner and outer introducer segments join.Additional information received: it was stated the event directly affected patient, had to find alternate introducer.The event did not involve an urgent/life threatening medical situation, routine insertion.Additional information received 17 august 2023: the patient was in intensive care intubated, sedated, infusing vasopressors and in need of central line access.The defect was discovered upon trying to insert introducer and meeting significant resistance, almost recoiling.Introducer advanced through skin, but unable to access vein.No harm came to patient, this did not delay care, no negative impact noted.A new introducer kit was utilized and further picc placement was successful.
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.
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 a difficult insertion is confirmed but the exact cause remains unknown.Three photo samples of a microez microintroducer were provided for evaluation.The first image showed the distal end of the dilator and introducer sheath.Deformation on the sheath was observed.The second photo shows another angle of the damaged region.Inward bunching of the sheath tip was present.The third image is of a product sticker label indicating lot: rehn3194.Based on the information provided, possible contributing factors include advancement against resistance, steep insertion angle, and inadequate skin nick.Since bunching of the sheath and evidence of a difficult insertion was noted, the complaint is confirmed but the exact cause remains unknown.
Event or Problem Description
It was reported by customer that the introducer would not advance.When it was removed and inspected, a notch was noted where the inner and outer introducer segments join.Additional information received: it was stated the event directly affected patient, had to find alternate introducer.The event did not involve an urgent/life threatening medical situation, routine insertion.Additional information received 17 august 2023: the patient was in intensive care intubated, sedated, infusing vasopressors and in need of central line access.The defect was discovered upon trying to insert introducer and meeting significant resistance, almost recoiling.Introducer advanced through skin, but unable to access vein.No harm came to patient, this did not delay care, no negative impact noted.A new introducer kit was utilized and further picc placement was successful.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER, BELDAR NG)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17491540
• Report Number: 3006260740-2023-03422
• Device Sequence Number: 7872160
• Product Code: LJS
• UDI-Device Identifier: 00801741155154
• UDI-Public: (01)00801741155154
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D5
• Device Lot Number: REHN3194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 10/10/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/25/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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 Sex: Unknown