MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0202250

Device Problems Defective Component (2292); Material Protrusion/Extrusion (2979)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported the device exhibits a wire protruding from the needle flash notch.No other information was provided.

Event Description

It was reported the device exhibits a wire protruding from the needle flash notch.No other information was provided.

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 the wire protruding from the flash port of the needle was confirmed.The product returned for evaluation was one accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The safety button was depressed and the needle was partially withdrawn into the housing.The needle protruded from the flash notch, preventing complete needle withdrawal.The guidewire was intact.Microscopic inspection of the wire confirmed it to be intact.Inspection of the needle bevel was unremarkable.The misdirection of the needle prevented the safety mechanism from fully activating.The needle misdirection appeared to have been caused by wire advancement against resistance, such as into tissue and the use residues suggested that attempted advancement occurred during attempted device placement.H3 other text: evaluation findings are in section h.11.

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 the wire protruding from the flash port of the needle was confirmed.The product returned for evaluation was one accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The safety button was depressed and the needle was partially withdrawn into the housing.The needle protruded from the flash notch, preventing complete needle withdrawal.The guidewire was intact.Microscopic inspection of the wire confirmed it to be intact.Inspection of the needle bevel was unremarkable.The misdirection of the needle prevented the safety mechanism from fully activating.The needle misdirection appeared to have been caused by wire advancement against resistance, such as into tissue and the use residues suggested that attempted advancement occurred during attempted device placement.

Event Description

It was reported the device exhibits a wire protruding from the needle flash notch.No other information was provided.

• Brand Name: ACCUCATH 20 GX2.25
• 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
• MDR Report Key: 11061887
• MDR Text Key: 223799330
• Report Number: 3006260740-2020-21050
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (y/n): N
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

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
• Device Operator: Health Professional
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/26/2021; 01/26/2021
• Supplement Dates FDA Received: 02/26/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 94