MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx1755 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i couldn¿t pass the guide wire through the needle with the blue arrow to it.If you look where the blue arrow is compared to the one that worked, there is a large metal piece (or something similar).That is where the guide wire would not pass at." additional info.Received 04/28/2022: was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.
Event or Problem Description
It was reported "i couldn't pass the guide wire through the needle with the blue arrow to it.If you look where the blue arrow is compared to the one that worked, there is a large metal piece (or something similar).That is where the guide wire would not pass at.Additional info.Received 04/28/2022.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.
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: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty advancing the guidewire through the introducer needle due to an obstructing metal piece was inconclusive with the provided information.A photograph was provided for review which depicted two 21ga introducer needles.A blue arrow had been digitally drawn on the image and pointed towards the needle cannula within one of the introducer needles.Blood residue was seen within both needles and the needle cannula appeared similar in both.No apparent unexpected metallic piece was seen within the photographs and it was likely that the object which appeared foreign was the needle cannula.No observable evidence suggested the cause of the difficulty advancing the guidewire through the needle.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.This event will be recorded for future trending and monitoring of this complaint type.

• Brand Name: POWERPICC PROVENA 5F DL FT 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14399972
• Report Number: 3006260740-2022-01784
• Device Sequence Number: 17505791
• Product Code: LJS
• UDI-Device Identifier: 00801741154850
• UDI-Public: (01)00801741154850
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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): 06/24/2022

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: S1275108FD2
• Device Lot Number: REFX1755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 98 KG