MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC HF (HIGH FLOW), 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

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	12/10/2024
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
Customer reported a picc kinked at approximately the 3cm depth mark near the insertion site 13 days after insertion.The picc was inserted on (b)(6) 2024 in the lue, with 55cm total length and 4cm left external, secured with statlock.The catheter had not required tpa during the dwell period.Picc was removed.
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 catheter kinking was confirmed for five events, but the cause is unknown.Six radiographic images were returned for evaluation.Each radiographic image represented different patients and dates of events.The angle of one of the images (grid row 3) resulted in overlapping of the catheter tubing which prevented definitive evaluation for a kink.Three of the images (grid rows 1,2 & 4) showed a kink at either the skin insertion site or the venous insertion site.The exact mechanism which caused these kinks could not be determined but possible contributing factors could include patient positioning (flexure of the arm), catheter securement, or anatomical variables.One of the images (grid row 5) showed a kink/bend in the catheter as it went into the azygous vein or doubled back within the right subclavian/ij/innominate veins.A possible contributing factor could include a stricture in the svc.The catheter in the last image (grid row 6) was looped into the right ij and was kinked at the top of the loop.The location of the loop was likely constricted by the right ij, resulting in the kink.The locations of the kinks, as well as possible contributing factors, varied between the returned events and no singular root cause could be assigned for the kinks.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC HF (HIGH FLOW), 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: chelsea raehl ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21313963
• Report Number: 3006260740-2025-00343
• Device Sequence Number: 18354788
• Product Code: LJS
• UDI-Device Identifier: 00801741034657
• UDI-Public: (01)00801741034657(11)240819(17)251130(10)REJT1374
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 1385108QD
• Device Lot Number: REJT1374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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 Sex: Unknown