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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"; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2018
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 manufacturer has received a photo sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebt0392 showed five other similar product complaint(s) from this lot number.The complaints for this lot number (rebt0392) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that the packaging had warped, causing the paper seal to lift, resulting in compromising the sterility of the product.The issue was reported on 6 devices of the same batch code.This report addresses the second needle.
 
Event Description
It was reported that the packaging had warped, causing the paper seal to lift, resulting in compromising the sterility of the product.The issue was reported on 6 devices of the same batch code.This report addresses the second needle.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a compromised seal between the tyvek lid and the rigid plastic tray was confirmed and the cause appeared to be associated with prolonged exposure to excessive heat.The source of heat was inconclusive.Two photographs were provided for investigation.The physical samples were subsequently returned.All six huber plus trays from lot rebt0392 exhibited deformation, which appeared to a result of heat damage.The flanges were curled and the preformed features of the rigid tray were warped.Five of the six huber plus trays exhibited a breach in the sterile barrier.It appeared that the deformation of the tray caused portions of the tray flange to separate from the tyvek lid.Other portions of the lid remained sealed to the tray.The exposed portions of the tray flanges revealed evidence of material transfer where the tyvek lid had once been sealed to the tray flange.This type of damage can occur from prolonged exposure to excessive heat, and the damage was most likely associated with shipping or environmental conditions outside bard control.Autoclaving can also cause excessive heat.The trays should not be re-sterilized.The case label for this product states, ¿do not use if package is damaged¿.
 
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Brand Name
HUBER PLUS 20G X .0.75"
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8034045
MDR Text Key126084284
Report Number3006260740-2018-03102
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741065620
UDI-Public(01)00801741065620
Combination Product (y/n)N
PMA/PMN Number
K993848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model NumberN/A
Device Catalogue Number012034
Device Lot NumberREBT0392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Event Location Hospital
Date Manufacturer Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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