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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¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Fluid Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/20/2018
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 that blood leaked from the joint of a bd insyte¿ autoguard¿ bc shielded iv catheter after saline puncture. There was no report of exposure, injury, or medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields. This supplemental event attributed to: other. Device single use?: no. Device returned to manufacture: yes. Review of the dhr revealed all required challenges samples and set-up and in- process testing was performed per specification in accordance with the quality 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. Received one used catheter/adapter assembly with an opened package from catalog number 381023, lot number 8036866 and two syringes with attached extension tubing. Visual/microscopic examination: there was damage to the inner rim/inside the end of the adapter (luer). Water/air leak test: the water/air leak test was performed. No leakage was observed in any area of the used catheter/adapter. The photo provided displayed the same findings as that of the returned unit. Although the defect leakage not confirmed; the damage to the inner rim of the adapter could result in an open path where air could be introduced, or leakage could occur in the clinical setting. Probable root cause: manufacturing ¿ there were known alignment issues with line 12, zone 5 during this period of time although no damage to the adapter was detected. The damage observed could occur within zones 5 when the equipment is lowered inside of the adapter inadvertently damaged the interior due to the incorrect alignment. Misalignments of the adapter relative to the equipment may cause this damage. Alignments are performed when they are determined to be necessary during set up or production. (b)(4) had been initiated to investigate this type incident and identity the root cause. Although the root cause was not determined for this particular complaint, (b)(4) was opened to address this similar issue.
 
Event Description
It was reported that blood leaked from the joint of a bd insyte autoguard bc shielded iv catheter after saline puncture. There was no report of exposure, injury, or medical intervention.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7692838
MDR Text Key114146019
Report Number1710034-2018-00395
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 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2021
Device Catalogue Number381023
Device Lot Number8036866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/16/2018 Patient Sequence Number: 1
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