MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC; 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	01/13/2026
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It was reported less than a month after magnetic navigation catheter placement, the catheter could not be withdrawn and exhibited blood reflux.Attempts to recanalize failed, necessitating unplanned catheter removal.Post-removal inspection revealed two kinks in the catheter approximately 20 cm from the puncture site, with deep creases.The patient denied strenuous physical activity.This catheter was used only once for chemotherapy.The catheterization team reported a smooth placement procedure.Chest x-ray revealed no skeletal abnormalities.No further 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 kinked catheter is confirmed, but the root cause could not be determined.One 4 fr s/l powerpicc catheter was returned for evaluation.One photograph and one video of a powerpicc catheter were returned for evaluation.An initial visual observation of the returned catheter showed blood use residues throughout the powerpicc device.Two circumferentially aligned kinks were observed; one kink was observed at the 20 cm depth marker, and the second kink was observed just distal to the 21 cm depth marker.A functional test of attempting to infuse water into the catheter using a 12 ml syringe revealed the catheter was occluded with blood.No leaking was observed.A microscopic observation revealed circumferentially aligned kinks at the 20 cm depth marker and just distal to the 21 cm depth marker.The catheter tubing appeared to have an overall elliptical shape at the kink sites.No root cause could be determined for the kinking of the catheter; however, possible causes of failure include repetitive movement of the device while the picc is in place, kinking caused by physiological placement location in the patient, or other unknown clinical or environmental circumstances.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24192569
• Report Number: 3006260740-2026-00235
• Device Sequence Number: 7893802
• Product Code: LJS
• UDI-Device Identifier: 00801741218132
• UDI-Public: (01)00801741218132(11)241223(17)270731(10)REJX3167
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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 Model Number: N/A
• Device Catalogue Number: C1174118
• Device Lot Number: REJX3167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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