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 Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "(b)(6) 2022 line flushed well and had blood return when holding light traction on external portion of line but occluded when traction removed.Securacath removed but problem persisted with statlock in place.After x-ray confirmed kink, line retracted 3-4 cm and then brisk blood return." no other information was provided.
Additional Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regq3272 showed no other similar product complaint(s) from this batch number.
Event or Problem Description
It was reported by the customer "on (b)(6) 2022 line flushed well and had blood return when holding light traction on external portion of line but occluded when traction removed.Securacath removed but problem persisted with statlock in place.After x-ray confirmed kink, line retracted 3-4 cm and then brisk blood return." no other information was provided.Additional information received on 2/28/2023: customer reports they were able to use the picc until the end of therapy after it was retracted 3cm.The event did not occur during an urgent or life-threatening medical circumstance and did not result in a clinically significant delay in therapy.
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 kink in the catheter was confirmed but the exact cause is unknown.A single ap chest radiograph was returned for evaluation of this complaint.The image included the right upper arm and right-sided picc.The implicated product was a 4fr d/l powerpicc provena catheter.Two kinks were seen in the image; one of the kinks was at the skin entrance site and the other kink was visible at the entrance into the vein.It was reported that slight traction on the catheter allowed flow through the lumen.It is likely that the slight traction reduced the severity of the observed kink.Possible contributing factors for the kinks in the catheter could include patient anatomy (e.G., muscle or fascial layers), catheter placement (e.G., angle of entry into the vein) or securement.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.
Event or Problem Description
It was reported by the customer "on (b)(6) 2022 line flushed well and had blood return when holding light traction on external portion of line but occluded when traction removed.Securacath removed but problem persisted with statlock in place.After x-ray confirmed kink, line retracted 3-4 cm and then brisk blood return." no other information was provided.Additional information received on 2/28/2023: customer reports they were able to use the picc until the end of therapy after it was retracted 3cm.The event did not occur during an urgent or life-threatening medical circumstance and did not result in a clinically significant delay in therapy.
Event or Problem Description
It was reported by the customer "(b)(6) 2022 line flushed well and had blood return when holding light traction on external portion of line but occluded when traction removed.Securacath removed but problem persisted with statlock in place.After x-ray confirmed kink, line retracted 3-4 cm and then brisk blood return." no other information was provided.Additional information received 2/28/2023: customer reports they were able to use the picc until the end of therapy after it was retracted 3cm.The event did not occur during an urgent or life-threatening medical circumstance and did not result in a clinically significant delay in therapy.Additional information received 5/25/2023: the catheter was inserted 13cm above the antecubital fossa and 3cm left external to the patient.
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.

• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16461007
• Report Number: 3006260740-2023-00591
• Device Sequence Number: 6573120
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: REGQ3272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• 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: 02/28/2023; 05/17/2023; 05/25/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/27/2023; 05/23/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: 39 YR
• Patient Sex: Unknown
• Patient Weight: 54 KG