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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 381423
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that a different bd product was found in a box for bd insyte¿ autoguard¿ shielded iv catheter(s). There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
No samples were returned in support of this complaint. Two photographs were returned of three samples. The photographs revealed one opened dispenser with the label identifying the product as part #381423. Lot #8057880 and three sealed units (blister packs which were identified by the top web sleeve as part#381423, lot # 8057880. A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications. Investigation conclusion: manufacturing (packaging) - the root cause was operator error during selection of the print sleeve to print the unit label information. Unit labels are setup/printed by an operator and verified by a cill or quality technician, but the error was not identified during this verification or other in-process inspections of the affected product (pallet 17). Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other. Device single use?: no. Device returned to manufacture: no.
 
Event Description
It was reported that a different bd product was found in a box for bd insyte autoguard shielded iv catheter(s). There was no report of exposure, injury or medical intervention.
 
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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
MDR Report Key7669483
MDR Text Key113642624
Report Number1710034-2018-00391
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814238
UDI-Public30382903814238
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2021
Device Catalogue Number381423
Device Lot Number8057880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/09/2018 Patient Sequence Number: 1
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