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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
The information provided by bd 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 bd.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds1094 showed 68 other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the plastic packaging is deformed, which leads to the loss of sterility of certain needles.It was state that the valve on the y-site is also deformed causing leaking.It was stated this occurred with 40 needles.This report addresses 2 of 40.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged packaging is confirmed; however, the exact cause is unknown.One photograph of two 20 g huber plus infusion sets with y-sites was returned for evaluation.An initial visual observation of the photograph showed the plastic trays of the infusion set packaging were warped, and the lid of the package appeared to be separated from the plastic tray on both samples.One of the valved y-sites also appeared to be warped and elliptical in shape; however, this was difficult to confirm from the returned photograph.While the warped packaging could be confirmed from the returned photograph, it was not possible to determine the root cause of this damage.However, possible causes include excessive or prolonged exposure to heat.A lot history review (lhr) of reds1094 showed 68 other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the plastic packaging is deformed, which leads to the loss of sterility of certain needles.It was state that the valve on the y-site is also deformed causing leaking.It was stated this occurred with 40 needles.This report addresses 2 of 40.
 
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Brand Name
HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10072439
MDR Text Key191891509
Report Number3006260740-2020-01767
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741065637
UDI-Public(01)00801741065637
Combination Product (y/n)N
PMA/PMN Number
K993848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberN/A
Device Catalogue Number012034NY
Device Lot NumberREDS1094
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2020
Event Location Hospital
Date Manufacturer Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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