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 Material Frayed (1262); Component Missing (2306); Material Deformation (2976)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeq4026 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported accucath iv 20g needle for a us guided iv insertion in the left forearm.The accucath was center of the vein on the us and had a flash in the needle.Rn fed in the guide wire with no resistance and no pain noted.Rn slid the catheter over the guidewire into the patient and at the end the patient said it was painful.When rn removed the accucath needle from the patient the needle did not fully collapse back into the needle system and the guide wire was crooked in the system.The guide wire normally has a curl at the tip and this curl was missing.Rn checked the system before using it and noted a curl on the guide wire.

Event Description

It was reported accucath iv 20g needle for a us guided iv insertion in the left forearm.The accucath was center of the vein on the us and had a flash in the needle.Rn fed in the guide wire with no resistance and no pain noted.Rn slid the catheter over the guidewire into the patient and at the end the patient said it was painful.When rn removed the accucath needle from the patient the needle did not fully collapse back into the needle system and the guide wire was crooked in the system.The guide wire normally has a curl at the tip and this curl was missing.Rn checked the system before using it and noted a curl on the guide wire.

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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken guidewire is confirmed.One accucath device was returned for evaluation.An initial visual observation showed the device was returned without a catheter, and the safety mechanism of the device was observed to have been activated but the needle tip remained protruding from the distal end of the housing.The guidewire was observed protruding from the flash groove of the needle when the needle was advanced, and the guidewire was found to be broken.A microscopic observation revealed the break site of the guidewire was tapered and curved with a granular surface texture, which is characteristic of a tensile (pulling) failure.Advancement of the guidewire against resistance (such as against tissue) can cause the guidewire to become caught in the flash groove of the needle.The shape and texture of the break in the guidewire of the returned device suggest the guidewire was also retracted against resistance, which ultimately caused the guidewire to break.The product ifu warns: ¿do not force or retract the guidewire.Retracting the guidewire may increase the risk of guidewire damage.If the guidewire must be retracted, remove the entire device to prevent the needle from damaging or shearing the guidewire.¿ h3 other text : evaluation findings are in section h.11.

• 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: 11140629
• MDR Text Key: 227510669
• Report Number: 3006260740-2020-21233
• 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
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: REEQ4026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR