MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
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 complaint of difficulty obtaining an ecg waveform is confirmed; however, the root cause could not be determined.The product returned for evaluation was a 3cg stylet.The white cord was cut and the plastic pin was not returned.Two pieces of the distal end of the stylet were broken off and returned for evaluation.Microscopic inspection of one of the break sites on the stylet revealed the core wire was slightly curved leading to the break.The break surface of the core wire was observed to be uneven with some of the edges tapered into a point.Regions of increased luster were also observed on the surface of the break.The broken stylet likely contributed to difficulty obtaining an ecg waveform.However, other factors may have also contributed such as a poor connection between the leads assembly and the stylet or excessive manipulation of the stylet during use.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that during insertion there was no ecg reading from the wire in the picc to the sherlock.After troubleshooting to ensure the ecg leads were correctly on the patient, the fin on the sherlock, and the connection from the sherlock to the machine.Still nothing worked.The wire inside the picc was removed as looked at and there were two places from the tip extending 3 inches that appeared bent.The piece closes to the tip of the wire broke off in 3 pieces (outside of the patient).No other information was provided.
Event or Problem Description
It was reported that during insertion there was no ecg reading from the wire in the picc to the sherlock.After troubleshooting to ensure the ecg leads were correctly on the patient, the fin on the sherlock, and the connection from the sherlock to the machine.Still nothing worked.The wire inside the picc was removed as looked at and there were two places from the tip extending 3 inches that appeared bent.The piece closes to the tip of the wire broke off in 3 piece (outside of the patient).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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20091890
• Report Number: 3006260740-2024-04795
• Device Sequence Number: 15369529
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: (01)00801741154904(11)240318(17)250531(10)REJN3811
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD2
• Device Lot Number: REJN3811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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