MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS (3CG, GUARDIVA, 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	07/20/2024
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported via medsun, during ultrasound assisted picc (peripherally inserted central catheter) line placement (4 fr single lumen) using modified seldinger technique at the patient's right brachial vein, staff met resistance once the picc was inserted 7 cm.Staff removed picc with massaging of the arm and vessel.Upon removal of the picc with introducer, it was found the picc was tied in a knot at the last 1.5 cm area.New kit was obtained and successfully placed.Additional information received 08/29/2024: it was reported, no harm to patient.Staff obtained a new kit and placed picc line without issue.No other information was provided.
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 knotted catheter is confirmed; however, the exact cause is unknown.Two photographs of a powerpicc were returned for evaluation.An initial visual observation of the photographs showed a tight knot near the distal end of the catheter.Use residue was observed on the device in the returned photographs.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported via medsun, during ultrasound assisted picc (peripherally inserted central catheter) line placement (4 fr single lumen) using modified seldinger technique at the patient's right brachial vein, staff met resistance once the picc was inserted 7 cm.Staff removed picc with massaging of the arm and vessel.Upon removal of the picc with introducer, it was found the picc was tied in a knot at the last 1.5 cm area.New kit was obtained and successfully placed.Additional information received 08/29/2024: it was reported, no harm to patient.Staff obtained a new kit and placed picc line without issue.No other information was provided.

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS (3CG, GUARDIVA, 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20205380
• Report Number: 3006260740-2024-05177
• Device Sequence Number: 17830174
• Product Code: LJS
• UDI-Device Identifier: 00801741154928
• UDI-Public: (01)00801741154928(17)250831(10)REJR1345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S1173108D3
• Device Lot Number: REJR1345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: 79 YR
• Patient Sex: Male