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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 381467
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2017
Event Type  malfunction  
Manufacturer Narrative
Results: bd's quality engineer inspected the returned unit and confirmed the package was received open/partially peeled. The analysis conducted revealed an adequate amount of top web adhesive which was within specifications. The returned device was tested and retraction was successful as there was no delayed reaction to the needle retracting. We were unable to determine a root cause for this incident based on the provided sample. The samples were visually and microscopically evaluated and the customer's indicated failure mode for leakage with the incident lot was observed. A device history record review showed no non-conformances associated with this issue during the production of this batch. Conclusion: the defect package seal integrity poor/questionable, as stated in the description of the complaint was confirmed with the returned unit. Even though the package was partially opened, all the processes characteristics that directly influence the seal strength were observed to be within specification. No anomalies were found. The defect of needle retraction failure as stated as the reported coded was not confirmed with the returned units. No physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button. Package seal integrity: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect. Needle retraction failure: the returned units did not display any adverse characteristics that would contribute to the defect the customer experienced. The defect that was described could not be confirmed or replicated with the returned representative unit. The actual unit described in the incident report was not returned for evaluation. Refer to (b)(4).
 
Manufacturer Narrative
(b)(6). 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 several bd insyte¿ autoguard¿ shielded iv catheter(s) experienced a sterile breach (¿package spontaneously opening¿). It was also reported that resistance occurred when using the safety mechanism and the needle doesn't retract fully. There was no report of injury or medical interventions.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7089331
MDR Text Key265121205
Report Number1710034-2017-00432
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2019
Device Catalogue Number381467
Device Lot Number6237840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2017 Patient Sequence Number: 1
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