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	07/31/2023
Type of Reportable Event	Malfunction
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 info from customer: (31-jul-2023) item was not saved.Directly affected patient - had to find alternate introducer.Routine insertion.Additional info from customer: (17-aug-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.It did not involve life threatening medical situation.
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 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.
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 following investigation elements were determined to be applicable and were completed as part of this investigation: ¿ sample analysis ¿ review of risk documentation based on a review of this information, the following was concluded: the complaint of a damaged microintroducer sheath is confirmed; however, the root cause could not be determined.One photograph of a microintroducer was returned for evaluation.An initial visual observation of the photograph showed the distal portion of the microintroducer sheath was damaged and plastically deformed.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.
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 info from customer: ((b)(6) 2023) item was not saved.Directly affected patient - had to find alternate introducer.Routine insertion.Additional info from customer: ((b)(6) 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.It did not involve life threatening medical situation.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17603355
• Report Number: 3006260740-2023-03648
• Device Sequence Number: 20373940
• 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
• Report Date (Section B): 10/27/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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