MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported (b)(6) 2025 @ 1730 - lue triple lumen picc placed - confirmed cavoatrial junction with sherlock 3cg.Picc total length: 44cm, external marking: 0cm.(b)(6) 2025 @ 1336 - ct angio pulmonary incl post processing performed; image captured during study showing picc tip still cavoatrial junction.(b)(6) 2025 @ 0611 - chest 1 view shows picc malposition.Cta pulmonary study performed injected at 4ml/sec.No further information 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 malpositioned catheter tip was confirmed but the cause is unknown.Two chest radiographs and an ecg printout were returned for evaluation.The ecg printout appeared unremarkable and noncontributory to the reported malposition.The first image was a fluoroscopic frontal chest image that showed a left-sided picc with the tip overlaying the cavoatrial junction.There were no breaks, kinks, or catheter folding/coiling present in this image.The second image showed the left-sided picc with its tip in the right subclavian vein.The catheter was kinked and folded back upon itself.It appears that the catheter became malpositioned after initial product placement.However, the exact mechanism that caused the malposition is unknown.Possible contributing factors could include physiological variables or jetting of fluid from the catheter tip during power injection.Spontaneous catheter tip malposition is a potential complication listed in the product ifu.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA
• 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: 24780540
• Report Number: 3006260740-2026-02275
• Device Sequence Number: 17675809
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178(11)250319(17)260228(10)REKN1302
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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 Expiration Date: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: S1385108D5
• Device Lot Number: REKN1302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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