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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 1 IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problems Pain (1994); Discomfort (2330)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant. [(b)(4)].
 
Event Description
It was reported via medwatch "infant pediatric patient access with a port-a-cath (pac) needle. Iv pump alarming downstream occlusion throughout the shift. The pac safety needle was retracting out of the port, requiring reinforcement of the needle underneath the dressing. This was causing stress and pain for the patient. ".
 
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Brand NameMINILOC SAFETY INFUSION SET 22G X 1 IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key8579286
MDR Text Key144257088
Report Number3006260740-2019-01278
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2019,05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0632210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/17/2019
Event Location Hospital
Date Report to Manufacturer04/17/2019
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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