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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25 CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25 CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
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 a bent accucath was confirmed; however, the root cause was not identified. The product returned for evaluation was one 20ga x 1. 25¿ accucath peripheral iv catheter assembly. No obvious usage residues were observed. The needle shaft exhibited a sharp bend just distal of the needle carrier. Microscopic inspection of the needle tip was unremarkable. Inspection of the bend site did not reveal any surface damage. While a sharp bend in the needle shaft was observed, no evidence was observed that identified the cause of the bend. 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 redp0679 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that prior to use when opening the package, end-user noticed the catheter bent at hub of catheter. Product was quarantined and not used on patient.
 
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Brand NameACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key9344744
MDR Text Key167174370
Report Number3006260740-2019-03592
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0201250
Device Lot NumberREDP0679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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