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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that " defective picc lines.We retained only the tracking wire and its components.The event directly involved patient care.Event occurred during the sterile insertion procedure of peripheral inserted central catheter placement.The failure point is the 3cg tracking wire grommet with poor seal closure.The yellow grommet is not fully sealed/tight around the 3cg wire causing air to be drawn into the catheter during aspiration for blood check and or during flushing.It also is so loose and the wire does not remain secure and migrates.The migration is minimal and is usually less than a couple millimeters there is still the potential of further migration.There were no patient injury during procedure.Interventions included attempting to remedy any user error such as checking that tracking wire connection was fully secured ensuring this was not the point of air infiltration into catheter/syringe.Checking that proper connection of flush syringe was fully secured to luer connection to ensure this was not the failure point.Interventions that helped remedy the issue were plugging grommet that 3cg wire threads though with thumb to help provide a better seal and prevent air infiltration.".
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.
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 leaking stopper was confirmed.The returned sample was found to exhibit the same features as a previously investigated event, and the root cause was found to be within the scope.
Event or Problem Description
It was reported by customer that " defective picc line.We retained only the tracking wire and its components.The event directly involved patient care.Event occurred during the sterile insertion procedure of peripheral inserted central catheter placement.The failure point is the 3cg tracking wire grommet with poor seal closure.The yellow grommet is not fully sealed/tight around the 3cg wire causing air to be drawn into the catheter during aspiration for blood check and or during flushing.It also is so loose and the wire does not remain secure and migrates.The migration is minimal and is usually less than a couple millimeters there is still the potential of further migration.There were no patient injury during procedure.Interventions included attempting to remedy any user error such as checking that tracking wire connection was fully secured ensuring this was not the point of air infiltration into catheter/syringe.Checking that proper connection of flush syringe was fully secured to luer connection to ensure this was not the failure point.Interventions that helped remedy the issue were plugging grommet that 3cg wire threads though with thumb to help provide a better seal and prevent air infiltration.".

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18302236
• Report Number: 3006260740-2023-05621
• Device Sequence Number: 17888305
• Product Code: LJS
• UDI-Device Identifier: 00801741155031
• UDI-Public: (01)00801741155031
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 01/24/2024

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S1173108D4
• Device Lot Number: REHS1962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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