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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381423
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation: investigation summary: dhr review was performed on the following lot number: 7193609 ¿ the lot number was built on afa line 2, from july 17, 2017 thru july 25, 2017. The review of the dhr revealed: according to the line clearance for zone 5; the previous work was item number was ns381523, lot number 2142680 7193609 ¿ the lot number was packaged on afa packaging 11, from july 21, 2017 thru july 26, 2017. The review of the dhr revealed: according to the line clearance positions a, b and c; the previous work was item number was ns381444, lot number 7191687. Observations and testing: received one unused iag 22ga unit in a sealed package from the lot number 7193609. Observed the product inside of the sealed package was an 18ga unit. The print on the paper top web shows that the ref # identifies the product as 381423; which is 22ga iag. The returned unit provided for evaluation revealed 18ga unit sealed in22ga package. Investigation conclusion: the defect of label content incorrect; as stated in the subject of the pir was confirmed with the returned unit. The print on the paper top web shows that the ref # identifies the product as 381423; which is 22ga iag. The product inside the sealed package is an 18ga unit. The customer experienced was confirmed with the evaluation performed on the returned unit. Root cause description: relationship of device to the reported incident: packaging process comment: the product associated with this incident was caused by an inadequate line clearance per the packaging line clearance.
 
Event Description
It was reported that an 18 g catheter was found in a 22 g x 1. 00 in. Bd insyte¿ autoguard¿ shielded iv catheter package before use. No injury or medical intervention.
 
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Brand Name22 G X 1.00 IN. BD 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 Key6989144
MDR Text Key91362714
Report Number1710034-2017-00285
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2020
Device Catalogue Number381423
Device Lot Number7193609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2017
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: 10/30/2017 Patient Sequence Number: 1
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