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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC INTRAVASCULAR CATHETER Back to Search Results
Model Number AC0202250
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard 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 bard. The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of rebs1727 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the sales rep that the catheter broke off the hub of the accucath. No patient injury was reported.
 
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Brand Name20GA, ACCUCATH IV CATHETER, 2.25", BASIC
Type of DeviceINTRAVASCULAR CATHETER
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6786188
MDR Text Key82764568
Report Number3006260740-2017-01277
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Model NumberAC0202250
Device Catalogue NumberAC0202250
Device Lot NumberREBS1727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
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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