MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TPS STYLET 5F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported "not picking up ecg wave forms, p wave specifically.Cannot tell if it's the sherlock sensor or the picc.An echo was taken due to patient symptoms and showed the picc tip was in the right ventricle.".
Event or Problem Description
It was reported "not picking up ecg wave forms, p wave specifically.Cannot tell if it's the sherlock sensor or the picc.An echo was taken due to patient symptoms and showed the picc tip was in the right ventricle.".
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 the internal wire leads would not give readings/hook up properly to the sherlock device is inconclusive due to the nature of the returned sample.One 3cg tls stylet was returned for evaluation.An initial visual observation showed that the returned 3cg tls stylet appeared intact, and the leads assembly was not returned for evaluation.No sharp bends were observed along the stylet.The product was functionally tested by attaching the stylet tether to a non-complainant leads assembly and sherlock sensor top plate.The attachment was unremarkable.A digital multimeter tester did not reveal any discontinuities with the complainant stylet.A steady resistance read at about 3.3 ohms.No deficiencies were discovered during evaluation of the returned sample; however, the potentially implicated leads assembly was not returned for evaluation.Consequently, this complaint is inconclusive at this time.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TPS STYLET 5F
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16765636
• Report Number: 3006260740-2023-01401
• Device Sequence Number: 17687569
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 05/12/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 1295108FD
• Device Lot Number: REGW0893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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 Sex: Unknown