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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP PORT ACCESS KIT 22G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP PORT ACCESS KIT 22G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number PA-0030YN
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/09/2021
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported the needles are severely leaking at the white connector.It was stated that there was not harm or injury to the patient.No other information was provided.
 
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Brand Name
SAFESTEP PORT ACCESS KIT 22G X 1 IN WITH Y-SITE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11745014
Report Number3006260740-2021-01588
Device Sequence Number4319047
Product Code FPA
UDI-Device Identifier00801741085512
UDI-Public(01)00801741085512
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K040527
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/13/2021
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 Catalogue NumberPA-0030YN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date04/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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