MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT; 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	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the wire got tied in a knot and was stuck in the patient's arm.Customer observed that the wire is "much thinner than it used to be".The patient reportedly had tortuous veins.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 regt3289 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
Customer reported the wire got tied in a knot and was stuck in the patient's arm.Customer observed that the wire is "much thinner than it used to be".The patient reportedly had tortuous veins.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 guidewire became knotted upon itself was confirmed.A photograph of the distal end of the implicated guidewire was returned for evaluation.Residual material, which appeared consistent with clinical use, was seen in the coils of the wire.The floppy distal tip of the guidewire was knotted upon itself.No damage was seen to the distal weld tip of the wire and no breaks were seen in the wire material.Due to the evidence of use on the guidewire, it appeared that the wire inadvertently folded over itself and was twisted into a knot during the procedure.Had the knot existed prior to use, the wire would not have fit through the needle.It was reported that the patient had tortuous veins which may have led to complications during insertion and may have contributed to the reported event.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.It was reported that the guidewire was much thinner than previously.However, the diameter of the guidewire could not be measured without receipt of the physical sample.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MAX BARRIER PLUS KIT
• 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: 16210191
• Report Number: 3006260740-2023-00066
• Device Sequence Number: 14538186
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S1395108D5
• Device Lot Number: REGT3289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/01/2023
• 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