MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reft4572 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by healthcare professional "during insertion and dilation step with the introducer/peel away i have notice unusual resistance.On occasions i remove the inner white dilator and do 2 step dilation.Despite this it feel that the lip/transition to the grey peel away part is too pronounced and gets caught often.Requiring more force than i¿d like to use.And at times buckles the sheath.This patient¿s skin was not abnormally tough.I have noticed this several times with both 3.5 and 4.5 fr dilators in recent months.Which is leading to more skin knicks with scalpel which is highly un-preferred and increases bleeding.".
Event or Problem Description
It was reported by healthcare professional "during insertion and dilation step with the introducer/peel away i have notice unusual resistance.On occasions i remove the inner white dilator and do 2 step dilation.Despite this it feel that the lip/transition to the grey peel away part is too pronounced and gets caught often.Requiring more force than i¿d like to use.And at times buckles the sheath.This patient¿s skin was not abnormally tough.I have noticed this several times with both 3.5 and 4.5 fr dilators in recent months.Which is leading to more skin knicks with scalpel which is highly un-preferred and increases bleeding.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed but the exact cause remains unknown.One 3.5 fr x 7cm microez microintroducer was returned for evaluation.The product sticker label indicated lot: ref (b)(4) and ref: (b)(4).Blood residue present within the device.Two bends present on the distal 3 cm of the dilator and sheath were observed.Distal sheath tip was observed to be bunched inwards and localized in one region of the orifice.Microscopic observation of the sheath tip revealed it to be bunched inwards with the orifice flared outwards.The deformation appears to be focused on one region of the sheath tip.Based on the damage observed, possible contributing factors include advancement against resistance and inadequate skin knick.The product instructions for use (ifu) states, ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision.¿ since the sheath tip was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: 12754906
• Report Number: 3006260740-2021-04672
• Device Sequence Number: 4985335
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 01/11/2022

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: S4153108D
• Device Lot Number: REFT4572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 48 KG