MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POLYURETHANE, POWERPICC PROVENA SOLO2, 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	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported 4fr dl picc catheter kinked in axillary area.Unable to resolve with retraction, needed to be removed and replaced.
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 it 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 was confirmed.The product returned for evaluation was one 4 fr d/l powerpicc solo.An initial visual observation of the returned catheter showed blood use residues throughout the device.A circumferential kink was observed at the 23 cm depth marker.A microscopic observation revealed the kink to have an overall elliptical shape of the catheter shaft and some slight wear and impressions at the kink site.No evidence of compression damage was observed along the catheter.The complaint of a kinked catheter is confirmed and was determined to be related to use of the product.Possible contributing factors to this failure may include insertion technique, maintenance technique, or other unknown physiological discrepancies allowing the catheter to kink use of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POLYURETHANE, POWERPICC PROVENA SOLO2, 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22243412
• Report Number: 3006260740-2025-03963
• Device Sequence Number: 9041845
• Product Code: LJS
• UDI-Device Identifier: 00801741155109
• UDI-Public: (01)00801741155109(11)241119(17)251130(10)REJX0241
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 08/20/2025

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: S1294108D4
• Device Lot Number: REJX0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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