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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Activation Problem (4042)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/30/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascws0163 showed one other similar product complaint(s) from this lot number.
 
Event or Problem Description
It was reported that the needle bent when inserted.Safety mechanism slips out when inserted.Grip to hold the needle very small and when holding the wings the needle slips back into the safety cap.
 
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Brand Name
MINILOC SAFETY INFUSION SET 20G X 1 IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9266894
Report Number3006260740-2019-03430
Device Sequence Number11224975
Product Code FPA
UDI-Device Identifier00801741048722
UDI-Public(01)00801741048722
Combination Product (Y/N)N
Initial Reporter CountrySA
PMA/510(K) Number
K050600
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberS02020-10
Device Lot NumberASCWS0163
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/10/2019
Initial Report FDA Received Date11/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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