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	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported last night (11/21) as we were placing a 3fr single lumen picc in a patient, we encountered an issue with the sherlock.There was an intermittent loss of the intravascular ecg line aka the "yellow" line (used to verify picc placement) that persisted despite trouble shooting efforts which included changing out the fin assembly and the electrodes.Ultimately picc tip verification was determined using cxr.
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 difficulty obtaining an internal ecg waveform was determined to be inconclusive.The products returned for evaluation were one sealed 3fr sl powerpicc solo catheter kit (unit 01) and one standalone tether connector cuff (unit 02).Amongst the components in the sealed kit were one 3cg stylet and one ecg leads assembly.Microscopic inspection and gross visual inspection of the returned components found that the standalone tether connector cuff was missing the tether wire.This may occur if the tether wire is forcibly pulled out of the connector cuff.Inspection of the sealed kit components was unremarkable.The 3cg stylet and leads assembly in the sealed kit were assembled with a non-complainant sherlock sensor top plate.The resultant assembly was tested for continuity using a digital multimeter.The resistance between the stylet and the top plate was steady and below 15 ohms.The resistances between the top plate and the snap electrode leads was steady and below 5 ohms.Another non-complainant sherlock sensor top plate that was filed to the minimum contact requirement was used to test the stylet and leads assembly again.No significant change was observed in the resistance readings and no discontinuities were observed.The standalone tether connector cuff was tested for continuity through the connector pin using a digital multimeter.The resistance through the pin was steady and below 5 ohms.No deficiencies were discovered during evaluation of the returned samples.The potentially implicated sherlock sensor, ecg leads assembly in unit 02, and stylet in unit 02 could not be examined for discontinuities/damage or connection issues.Therefore, this complaint is inconclusive at this time.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: 23768121
• Report Number: 3006260740-2025-09489
• Device Sequence Number: 21481322
• Product Code: LJS
• UDI-Device Identifier: 00801741155086
• UDI-Public: (01)00801741155086(11)250529(17)260430(10)REKR0952
• Combination Product (Y/N): Y
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 02/19/2026

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 Model Number: N/A
• Device Catalogue Number: S1193108D4
• Device Lot Number: REKR0952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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