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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that they are unable to draw blood back through the extension tubing on the stylet lumen of the picc during insertion.Sucking air not blood.This has occurred on 6 occasions not sure of dates.Some have had visible leaking of normal saline where the stylet exits the stopper.All picc's were flushed prior to insertion, customer was able to remove the stylet once inserted correctly and draw blood directly from the hub of the catheter without difficulty.The customer opened a kit from the same lot for a demonstration of the issue.This report addresses the demonstration lot device.
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 customer that they are unable to draw blood back through the extension tubing on the stylet lumen of the picc during insertion.Sucking air not blood.This has occurred on 6 occasions not sure of dates.Some have had visible leaking of normal saline where the stylet exits the stopper.All picc's were flushed prior to insertion, customer was able to remove the stylet once inserted correctly and draw blood directly from the hub of the catheter without difficulty.The customer opened a kit from the same lot for a demonstration of the issue.This report addresses the demonstration lot device.
Additional Manufacturer Narrative
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 through the t-lock septum was confirmed.A video of a functional test on a dual lumen powerpicc catheter was returned for evaluation.The t-lock assembly was attached to the red luer adaptor and the 3cg stylet was inlaid within the catheter lumen.The video focused on the t-lock assembly.When an attempt was made to aspirate fluid through the catheter and t-lock assembly, red fluid was aspirated.However, air was also seen entering into the syringe barrel, indicating a leak in the system.As the physical device was not returned, the sample could not be independently tested to determine the location of the leak.It was reported in the event description that some samples had visible leaking where the stylet traversed through the septum of the t-lock assembly.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TPS
• 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: 17959310
• Report Number: 3006260740-2023-04748
• Device Sequence Number: 17901290
• Product Code: LJS
• UDI-Device Identifier: 00801741086915
• UDI-Public: (01)00801741086915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• 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): 02/06/2024

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 1274118
• Device Lot Number: REHP0855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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