MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
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
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reft4463 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.".
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged midline catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The guidewire was advanced and exhibited a sharp bend at the exit site from the needle tip.The guidewire was intact.The catheter was withdrawn and the needle had punctured the catheter approximately midway along its length.Microscopic inspection of the perforation in the catheter wall revealed a glossy fracture surface.The fracture was diagonally aligned.Inspection of the catheter tip revealed deformation.The catheter fracture features and position were consistent with perforation by the tip of the guidewire needle.The guidewire and catheter tip deformation were consistent with attempted insertion against resistance.It appeared that initial device placement was attempted against resistance.Subsequent withdrawal of the catheter back onto the needle resulted in the catheter shaft being pierced by the needle tip.

• Brand Name: FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER
• 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: 12754915
• Report Number: 3006260740-2021-04671
• Device Sequence Number: 4550638
• Product Code: FOZ
• 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: K162377
• 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): 12/30/2021

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: F320108PT
• Device Lot Number: REFT4463
• 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: 12/30/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/07/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 101 KG