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

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Event 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.".

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 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.".

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
• Type of Device: 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
• MDR Text Key: 280518889
• Report Number: 3006260740-2021-04671
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 101 KG