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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381823
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Device returned to manufacture: yes.
 
Event Description
It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Received five unused iag 22ga units in partially opened packages and three unused representative iag 22ga units in sealed packages from the lot number 7110801.Customer identified the reported defect of open seals and documented the same with photographs.Five of the packages were partially opened at both end of the blister pack.The seals were not compromised in the representative units.The product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition, the paper top web of the returned unit was analyzed under uv light.The adhesive used to seal the top and bottom webs together is uv fluorescent.The analysis revealed an adequate transfer (adhesive) from the top web to the bottom web.The key variables that affect the seal are: seal transfer/ width and top web adhesive presence.Both of these variables were looked at during the investigation.The defect package seal integrity poor/questionable was confirmed with the returned units.Even though the packages were partially opened, all the processes characteristics that directly influence the seal were observed to be within specification.Dhr review was performed on the lot number 7110801: the lot number was manufactured on afa line 5 from april 25, 2017 thru april 30, 2017.Packaged on packaging line 11 from april 30, 2017 thru may 2, 2017.Review of the dhr¿s revealed all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7587809
MDR Text Key111043617
Report Number1710034-2018-00347
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2020
Device Catalogue Number381823
Device Lot Number7110801
Initial Date Manufacturer Received 05/29/2018
Initial Date FDA Received06/11/2018
Supplement Dates Manufacturer Received05/29/2018
05/29/2018
Supplement Dates FDA Received08/10/2018
09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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