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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 22G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS HUBER PLUS 22G X 0.75"; 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 10/28/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recr1129 showed thirteen other similar product complaint(s) from this lot number.The complaints for this lot number (recr1129) have been reported from the same facility in (b)(6).
 
Event Description
It was reported the device package was deformed on 14 devices (the sterility of device was suspected to be not in good condition).Devices were not used on patients.This report addresses the 12th device.
 
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 deformed packaging is confirmed and the cause appeared to be associated with prolonged exposure to excessive heat.Fourteen 22 ga x 0.75 in huber plus infusion sets in unopened packaging were returned for investigation.The plastic was observed to be warped and the flanges were partially separated from the tyvek packaging.The presence of the seal was observed; however, a complete separation from the seal was observed on two of the fourteen samples due to the deformation of the trays.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.The product ifu found on www.Bardaccess.Com states ¿do not use if package is damaged¿.
 
Event Description
It was reported the device package was deformed on 14 devices (the sterility of device was suspected to be not in good condition).Devices were not used on patients.This report addresses the 12th device.
 
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Brand Name
HUBER PLUS 22G 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 Key8095706
MDR Text Key128204663
Report Number3006260740-2018-03354
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741065712
UDI-Public(01)00801741065712
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
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 Received11/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number012234
Device Lot NumberRECR1129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2018
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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