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

Catalog Number	S1385108D5
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
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 it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that on (b)(6) 2026, a right upper extremity triple lumen picc was placed.Tip confirmation with sherlock 3cg was unsuccessful due to the patient being in atrial fibrillation.A chest xray was subsequently ordered, which initially demonstrated the picc tip terminating at the cavoatrial junction.The picc had a total catheter length of 43 cm with an external marking of 0 cm.The patient later underwent a ct of the abdomen and pelvis with contrast.A subsequent chest xray revealed malposition of the picc tip.Per the ct department, the study was performed using an injection rate of 4 ml per sec.The provider approved administration of an additional dose of contrast, as it appeared the patient first underwent a routine abdominal pelvic study and then required a true arterial study.The abdominal pelvic ct was injected at 2.5 ml per sec through the picc line, which should not have caused disruption of the catheter.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.
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 fluoroscopic images were returned for evaluation.The images were of the front chest coned down to the right upper chest.A right-sided picc was present in both images.In the first image the catheter tip was overlaying the cavoatrial junction while the second image showed the catheter coiled before the costoclavicular junction.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.
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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24769426
• Report Number: 3006260740-2026-02253
• Device Sequence Number: 10267997
• Product Code: LJS
• UDI-Device Identifier: 00801741155178
• UDI-Public: (01)00801741155178(11)250602(17)260430(10)REKR0294
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 04/30/2026
• Device Catalogue Number: S1385108D5
• Device Lot Number: REKR0294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• 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: 04/06/2026; 04/23/2026; 05/11/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/10/2026; 04/30/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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