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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Abdominal Distention (2601)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.
Event or Problem Description
It was reported via medsun: the patient continued to have abdominal distension the day of the incident for which an abdominal ultrasound was performed which showed "florid inflammatory changes noted in the right lower quadrant with aperistaltic thick-walled tubular structure present.Ct of abdomen and pelvis with intravenous contrast is recommended to better assess the etiology of the tubular structure with associated inflammatory changes." ct scan with iv contrast was performed, contrast pushed through the picc/midline catheter [peripherally inserted central catheter].The resulting image showed, "contrast material instilled within the anterior pelvis consistent with an extraluminal placement of the catheter tip." i was informed immediately upon this finding and the patient was immediately brought back to the picu [pediatric intensive care unit].The patient remained on bipap [bilevel positive airway pressure] settings without escalation in respiratory support.The abdomen upon arrival was soft, mildly distended, but appeared non-tender.Pediatric surgery and vascular surgery were both consulted and agreed to keep the catheter in place until the morning.Previously infusing ppn [peripheral parenteral nutrition] was switched to infuse in another piv [peripheral iv line].Lovenox, which had been scheduled for a newly discovered thrombus, was discontinued.The leg and abdomen were closely examined serially throughout the night.The leg's peripheral pulses remained 2+ with capillary refill <2 seconds, and the color remained pink and warm.The abdomen remained soft, with the same mild distension.Patient passed a bowel movement in the morning.The incident was disclosed to the parents immediately upon the patient's arrival to the unit.The plan to keep the catheter in place until the morning and to hold any additional lovenox doses were relayed to the parents and they were in agreement.

• 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: 22066479
• Report Number: 3006260740-2025-03280
• Device Sequence Number: 21219377
• Product Code: LJS
• UDI-Device Identifier: 00801741134104
• UDI-Public: (01)00801741134104(11)241002(17)251130(10)REJV3897
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: S1173108PD
• Device Lot Number: REJV3897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male