MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number	382557
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter was found before use with several malfunctions.The glue appeared disintegrated on the packages edges as ¿the peel apart edges were curled back and packages appeared to be spontaneously opening¿ this creating a sterile barrier breach.A safety failure was found as ¿the activation of the mechanical button does not appear to retract the stylet into the safety barrel without resistance.¿ there was no report of injury or medical intervention needed.
Additional Manufacturer Narrative
Results - bd received nine iag 16ga units from lot number 5121525.The defect of package seal integrity, as stated in the event description was confirmed with the returned unit.Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.The defect of needle retraction failure could not be confirmed, no physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button.No significant issues were found during the review of the device history record.Conclusion - complaint confirmed.Capa (b)(4) has been opened to address the package seal integrity issue (see capa (b)(4)).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7089437
• Report Number: 1710034-2017-00442
• Device Sequence Number: 1461686
• Product Code: FOZ
• UDI-Device Identifier: 30382903825579
• UDI-Public: 30382903825579
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 382557
• Device Lot Number: 5121525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other