MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Failure to Infuse (2340); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of refq1088 showed no other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer that the picc has great blood return and flush when patient's arm is abducted away from body.Both lumens of picc are not patent when arm is by the patient's side.This vat rn consulted with picc rn, on how to troubleshoot positional picc.Picc rn recommended pulling picc 0.5cm.This vat rn pulled picc 0.5cm during dressing changed.Picc has good blood return and flush in both lumens.No other information was provided.
Event or Problem Description
It was reported by the customer that the picc has great blood return and flush when patient's arm is abducted away from body.Both lumens of picc are not patent when arm is by the patient's side.This vat rn consulted with picc rn, on how to troubleshoot positional picc.Picc rn recommended pulling picc 0.5cm.This vat rn pulled picc 0.5cm during dressing changed.Picc has good blood return and flush in both lumens.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 difficulty infusing the catheter was confirmed but the cause is unknown.Two ap chest radiographs that were coned down to the right side were returned for evaluation.The implicated product was a 4fr d/l powerpicc provena catheter.The right-sided picc had two kinks overlaying the right axilla.The image with the time stamp of 22:51 appeared to have the catheter advanced more and was more looped than the previous image (time stamped at 22:49).It is likely that the kink in this location caused the difficulty infusing through the catheter.It was reported that flow could be restored to the catheter when the arm was abducted away from the body.Abducting the arm away from the body likely lessened the kink, allowing the catheter to be infused through.Possible contributing factors for the kink could include the patient anatomy (e.G.Anatomic variants in the right axilla or a valve catching on the catheter in that location) or catheter placement.The ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ and ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.¿ the report of a kinked catheter has been documented and will be monitored as part of complaint trending.H3 other text: evaluation findings are in section h11.
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.
Event or Problem Description
It was reported by the customer that the picc has great blood return and flush when patient's arm is abducted away from body.Both lumens of picc are not patent when arm is by the patient's side.This vat rn consulted with picc rn, on how to troubleshoot positional picc.Picc rn recommended pulling picc 0.5cm.This vat rn pulled picc 0.5cm during dressing changed.Picc has good blood return and flush in both lumens.Additional information received on 5/25/2023: catheter was inserted 8cm above the antecubital fossa and 3cm left outside the vessel.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• 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: 16483091
• Report Number: 3006260740-2023-00671
• Device Sequence Number: 12680571
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2023

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REFQ1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 05/25/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 05/23/2023; 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: 51 YR
• Patient Sex: Unknown
• Patient Weight: 57 KG