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	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
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 regv0508 showed one other similar product complaint(s) from this batch number.The complaints for this batch number have been reported from the same facility.
Event or Problem Description
It was reported by the customer, "seven days after insertion line kinked.On (b)(6) 2023 discussed with unit rn picc line now drawing blood and very hard to flush.Picc was declotted on (b)(6).Patient and mom state line is very positional and occluding often.Recommend chest xray with left arm included to check for kinks in line.Picc was rewired." no other information was provided.
Event or Problem Description
It was reported by the customer, "seven days after insertion line kinked.On (b)(6) 2023 discussed with unit rn picc line now drawing blood and very hard to flush.Picc was declotted on (b)(6) 2023.Patient and mom state line is very positional and occluding often.Recommend chest xray with left arm included to check for kinks in line.Picc was rewired." no other information was provided.Additional information received on 2/28/2023: it was reported by the customer "catheter was secured with securacath.".
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, "seven days after insertion line kinked.On (b)(6) 2023 discussed with unit rn picc line now drawing blood and very hard to flush.Picc was declotted on (b)(6) and (b)(6).Patient and mom state line is very positional and occluding often.Recommend chest xray with left arm included to check for kinks in line.Picc was rewired." no other information was provided.Additional information received on 2/28/2023: it was reported by the customer "catheter was secured with securacath.".
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 through the catheter was confirmed but the cause is unknown.Two radiographic images were returned for evaluation.The first image was a coned down ap image of the left elbow while the second image was an ap image of the chest that included the left elbow.The implicated product was a 4fr d/l powerpicc provena catheter with its tip overlaying the svc.It is possible that the tip of the catheter was occluded due to its location against the svc sidewall.In addition, a loop in the catheter was seen at the skin entrance site which likely resulting in a catheter kink.A small bend was also noted in the catheter line, at the costoclavicular junction.It is possible that the difficulty infusing through the catheter was caused either by the tip location or due to a kink/bend in the line.It was reported that the occlusion was positional, which could be explained by either of these issues.It is possible that the loop in the catheter was due to placement 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.¿ a review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The report of difficulty infusing the 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, "seven days after insertion line kinked.On (b)(6) 2023, discussed with unit rn picc line now drawing blood and very hard to flush.Picc was declotted on (b)(6) and (b)(6).Patient and mom state line is very positional and occluding often.Recommend chest xray with left arm included to check for kinks in line.Picc was rewired." no other information was provided.Additional information received on 2/28/2023: it was reported by the customer "catheter was secured with securacath." additional information received on 5/25/2023: catheter inserted 7cm above the antecubital fossa with 5cm left external to the patient.

• 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: 16475589
• Report Number: 3006260740-2023-00635
• Device Sequence Number: 15266431
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGV0508
• 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: 03/02/2023
• 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: 08/01/2022
• 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: 17 YR
• Patient Sex: Unknown
• Patient Weight: 49 KG