MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer "post picc procedure wire was inspected to have a significant kink toward the lower third just above the technology portion of the wire.No damage was noticed pre procedure and nothing was noted during placement to have caused the kink or feel the wire had a problem.Technology worked as intended to confirm via ecg." additional information received 5 june 2023: it was reported by the customer "no harm, injury, complication, or negative outcome occurred.After found out the bend picc wire, x-ray was requested to make sure the tip was in the appropriate location.".
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a kinked stylet was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 3cg tls stylet.The depicted device had been fully removed from its catheter.The stylet was placed on a drape.A sharp kink was visible within the plastic-coated region near the distal tip.The stylet appeared intact.Stylet deformation was evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the deformation.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include stylet insertion past the tip of the catheter following trimming and attempted stylet reinsertion following removal.
Event or Problem Description
It was reported by the customer "post picc procedure wire was inspected to have a significant kink toward the lower third just above the technology portion of the wire.No damage was noticed pre procedure and nothing was noted during placement to have caused the kink or feel the wire had a problem.Technology worked as intended to confirm via ecg." additional information received 5 june 2023: it was reported by the customer "no harm, injury, complication, or negative outcome occurred.After found out the bend picc wire, x-ray was requested to make sure the tip was in the appropriate location.".

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG TIP POSITIONING
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17139595
• Report Number: 3006260740-2023-02456
• Device Sequence Number: 12255374
• Product Code: LJS
• UDI-Device Identifier: 00801741155093
• UDI-Public: (01)00801741155093
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/31/2023

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: 1194108D4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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