MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH ACE INTRAVASCULAR CATHETER (20G); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reeq0703 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported "we are training on the device, our clinical nurse specialist was assisting with a placement when she discovered that the device inside the kit was bent on 7/13.Later on in the day we discovered a second device from the same box was also bent.Both devices are defective preventing the guidewire from deploying and the white button from engaging the safety mechanism.Neither device were placed in a patient." this report addresses the first device.

Event Description

It was reported "we are training on the device, our clinical nurse specialist was assisting with a placement when she discovered that the device inside the kit was bent on (b)(6).Later on in the day we discovered a second device from the same box was also bent.Both devices are defective preventing the guidewire from deploying and the white button from engaging the safety mechanism.Neither device were placed in a patient." this report addresses the first device.

Manufacturer Narrative

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 bent accucath needles was confirmed; however, the root cause was not identified.The product returned for evaluation was two 20ga x 2.25¿ accucath ace peripheral iv catheter assemblies.The first sample (sample 1) was received without the catheter.The second sample (sample 2) was received with the catheter overlaying the needle shaft.Both samples exhibited bends in the needle shafts at the exit sites from the carriers.Both safety buttons were depressed and both needles were partially withdrawn into the housings.The needle bends prevented wire mobility, which prevented full needle withdrawal into the housings.Microscopic inspection of the needle tips and wire coils was unremarkable.Bends were observed in both needle shafts, preventing activation of both safety mechanism; however, no evidence was discovered that informed the cause of those bends.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include device manipulation prior to or during attempted use.A lot history review (lhr) of reeq0703 showed three other similar product complaint(s) from this lot number.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (20G)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10368709
• MDR Text Key: 201755592
• Report Number: 3006260740-2020-02766
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (y/n): N
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REEQ0703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1