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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS ACCUCATH ACE INTRAVASCULAR CATHETER (20G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY Back to Search Results
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.
 
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Brand NameACCUCATH ACE INTRAVASCULAR CATHETER (20G)
Type of DeviceCATHETER,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 Key10368709
MDR Text Key201755592
Report Number3006260740-2020-02766
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741138010
UDI-Public(01)00801741138010
Combination Product (y/n)N
PMA/PMN Number
K162894
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberN/A
Device Catalogue NumberAC1202252
Device Lot NumberREEQ0703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No

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