MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "a piece of the rubber portion of the wire come off.It is the stopper for the wire that guides it in the picc.No issues related to the picc wire." no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regt6039 showed no other similar product complaint(s) from this lot number.
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.
Event or Problem Description
It was reported by the customer that "a piece of the rubber portion of the wire come off.It is the stopper for the wire that guides it in the picc.No issues related to the picc wire." 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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the septum had separated from the t-lock assembly was confirmed but the cause is unknown.A single photograph of the implicated 3cg tls stylet was returned for evaluation.The t-lock assembly and solo funnel connector were found with the stylet but appeared to have been slid off the stylet.The yellow septum had completely detached from the luer adaptor of the t-lock assembly and was still found around the stylet.The clear shrink band, used to hold the septum inside the luer adaptor, was not visible on the yellow septum.The sample was in a plastic biohazard bag with the sample tangled upon itself; therefore, a clear view of the t-lock assembly luer adaptor was not visible.It could not be determined from the photograph if the shrink tubing was still present on the luer adaptor and/or if the shrink tubing contained any damage which could have contributed to this event.There were no distinguishing features visible in the returned photographs which could aid in identification of a specific root cause.Possible contributing factors could include a damaged/defective shrink band/septum or damage during the clinical procedure (e.G., over pressurization).A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.This type of complaint will continue to be monitored as part of ongoing complaint trending.
Event or Problem Description
It was reported by the customer that "a piece of the rubber portion of the wire come off.It is the stopper for the wire that guides it in the picc.No issues related to the picc wire." no other information was provided.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16109652
• Report Number: 3006260740-2022-06009
• Device Sequence Number: 20493048
• Product Code: LJS
• UDI-Device Identifier: 00801741154898
• UDI-Public: (01)00801741154898
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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: S1294108D2
• Device Lot Number: REGT6039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 02/24/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/30/2023; 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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