MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA, 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	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, inserted a picc a week ago in patient.Vat rn was troubleshooting what appeared to be an occluded line.Patient was given 2 doses of cathflo and replaced with a midline after not successful in saving the line.The line had been inserted just before zero mark and at 3.5 mark noticed a bend.The bend appeared to be a weaken area of the catheter but it was not fractured in half.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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 causing an occlusion is confirmed and was determined to be use-related.One 4 fr d/l powerpicc catheter was returned for evaluation.One video of a d/l powerpicc catheter was returned for evaluation.An initial visual observation of the returned catheter showed blood use residues throughout the returned device.Two circumferential kinks were observed: one just distal of the 2 cm depth marker and the other between the 3 cm and 4 cm depth markers.A functional test of attempting to infuse water into each of the two lumens using a 12 ml syringe revealed no occlusion within the catheter shaft.The catheter was patent to infusion.A microscopic observation revealed ¿c¿ shaped impressions leading into the kinks.The catheter appeared to have an elliptical shape at the kink sites just distal of the 2 cm depth marker and between the 3 cm and 4 cm depth markers.The complaint of catheter kinks is confirmed and was determined to be related to insertion and/or maintenance techniques.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA, 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21978636
• Report Number: 3006260740-2025-02911
• Device Sequence Number: 7227670
• Product Code: LJS
• UDI-Device Identifier: 00801741216015
• UDI-Public: (01)00801741216015(11)240918(17)251130(10)REJV0895
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 06/30/2025

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: CK000987
• Device Lot Number: REJV0895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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