MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported 6/3 we had a picc that we drew back and noted air go into the syringe while we were checking for blood return.I immediately took picc out and put introducer cannula back in and we obtained a new picc.We re-examined the line and i had the clamp on the tubing attached to picc to show the leak i found when i evaluated the line after taking it out of the patient to see why when i puled back there was air in the syringe.No other 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.The complaint of a leak along the extension tubing is confirmed and was determined to be supplier related.One 4 fr s/l powerpicc solo with its 3cg t-lock assembly and stylet was returned for evaluation.An initial visual observation showed blood residues throughout the returned device.A functional test of attempting to infuse water into the t-lock assembly luer using a 12 ml syringe revealed a leak at the tubing/luer interface.A functional test of infusing dye water into the t-lock assembly using a 12 ml syringe to identify the flow path of the leak inside the luer revealed the fluid path could not be easily identified using the dye.A microscopic observation revealed a vacant space inside the luer where the tubing connects to the luer.An observation of the dye water inside the luer and tubing under the microscope revealed the leak appeared on the opposite side of the vacant space observed under the luer.Adhesive sections could be seen around the tubing at the tubing/luer interface, and the adhesive was observed to be disconnected from the green luer.A microscopic observation of the proximal end of the luer revealed no easily observable fluid path from the proximal end of the luer/tubing interface.Microscopic inspection of the luer/tubing interface revealed inadequate adhesive coverage at the tubing interface with the luer.This failure was determined to be related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC, 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22338378
• Report Number: 3006260740-2025-04325
• Device Sequence Number: 9126224
• Product Code: LJS
• UDI-Device Identifier: 00801741155048
• UDI-Public: (01)00801741155048(11)250315(17)260228(10)REKP0108
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 10/06/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 1174108D4
• Device Lot Number: REKP0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2025
• 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