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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/16/2025
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.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.
Event or Problem Description
It was reported by customer that the picc line cracked right outside of the insertion site.Iv team to bedside in the morning to access patient's left arm peripherally inserted central catheter (picc) dressing.Iv team notified bedside rn that patient's left arm picc dressing will need to be changed due to dressing lifting on the sides and that pediatric intensive care unit (picu) rns are able to change this patient's picc line dressing.Picc line flushing and blood return present, despite needing tissue plasminogen activator (tpa) at 6am.Bedside rn and a second rn changed patient's picc line.Picc line had newer statlock holding it in place.Second rn attempted to stabilize picc while bedside rn cleaned and put on new dressing.After dressing change was complete, bedside rn noticed bleeding at insertion site.Bedside rn flushed picc line easily and picc line still had good blood return.Rn notified fellow of bleeding at insertion site.Fellow to bedside to assess and ordered cxr to view placement of picc.Fellow ordered rn to call iv team to bedside to assess as well.Iv team to bedside to assess patient's left arm picc line.Iv team changed cap, flushed line, and tried for blood return when iv team stated "blood started pouring from site." per iv team, picc line cracked right outside of the insertion site, however still looked intact in the patient's body per chest-x-ray (cxr).Iv team held pressure and bedside rn called fellow to bedside.Fellow and attending discussed with interventional radiology (ir).Team decided that patient will go to ir in the morning to get picc rewired/fixed.Picc line still in patient's arm with dressing overtop and picc line tubing has 2 clamps holding picc line in place until the morning.No-no applied overtop to help protect picc line.Picu charge rn and attending notified and to bedside to assess.No other information was provided.

• Brand Name: POWERPICC SV (SMALL VEINS)
• 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: jomil padin ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22205974
• Report Number: 3006260740-2025-03880
• Device Sequence Number: 15175351
• Product Code: LJS
• UDI-Device Identifier: 00801741027567
• UDI-Public: (01)00801741027567(11)240211(17)271231(10)REJN1442
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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 Model Number: N/A
• Device Catalogue Number: 3173355
• Device Lot Number: REJN1442
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2024
• 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