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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AG BC GLOBAL YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AG BC GLOBAL YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381012
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that insyte ag bc global yel 24ga x 0.75in had hair in the seal of the package on 2 occasions before use.The following information was provided by the initial reporter: this is a repot about a foreign matter (hair) in the package.During inspection before use, the customer found hair in the seal of the package.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-15.H6: investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two unopened units and four photographs.Through the visual examination, a strand of hair was observed within the sealed package.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to human error in the packaging process.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that insyte ag bc global yel 24ga x 0.75in had hair in the seal of the package on 2 occasions before use.The following information was provided by the initial reporter: this is a repot about a foreign matter (hair) in the package.During inspection before use, the customer found hair in the seal of the package.
 
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Brand Name
INSYTE AG BC GLOBAL YEL 24GA X 0.75IN
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key10659911
MDR Text Key212768248
Report Number1710034-2020-00659
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 11/19/2020
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
Device Operator Other
Device Expiration Date01/31/2023
Device Catalogue Number381012
Device Lot Number0036689
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Initial Date Manufacturer Received 09/14/2020
Initial Date FDA Received10/10/2020
Supplement Dates Manufacturer Received11/19/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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