MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; 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	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "the complaint of the customer was that the rubber stopper at the end of the stylet t-lock assembly for picc placement is leaking whereas it never was before.He also stated that it looked like a new stylet stopper." no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that "the complaint of the customer was that the rubber stopper at the end of the stylet t-lock assembly for picc placement is leaking whereas it never was before.He also stated that it looked like a new stylet stopper." 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 complaint of a leak from the t-lock septum was inconclusive due to the sample condition.A single photograph of the implicated t-lock assembly and stylet was returned for evaluation.The t-lock assembly and stylet had been removed from the catheter.The stylet was seen traversing through the yellow septum of the t-lock assembly, as per design.No liquid was seen emanating from the septum of the t-lock device.However, it did not appear that the device was actively being infused when the photograph was taken.Without the physical sample, functional testing and microscopic examination of the septum could not be conducted.As the submitted photograph did not contain enough information to confirm the event or identify a specific root cause, this complaint will be recorded as inconclusive at this time.Possible contributing factors could include a damaged septum or over-pressurization.If the physical sample is received at a later date, this investigation will be updated with the relevant information.The report of a leak has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential manufacturing/supplier related issues.

• Brand Name: POWERPICC 4F SL 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16539977
• Report Number: 3006260740-2023-00815
• Device Sequence Number: 7118802
• Product Code: LJS
• UDI-Device Identifier: 00801741154836
• UDI-Public: (01)00801741154836
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 05/18/2023

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 1174108D2
• Device Lot Number: REGX0254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: Other
• Patient Sex: Unknown