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

Catalog Number	381467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8212900.Medical device expiration date: 2021-07-31.Device manufacture date: 2018-07-31.Medical device lot #: 8127892.Medical device expiration date: 2021-04-30.Device manufacture date: 2018-05-07.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 3 of the bd insyte¿ autoguard¿ shielded iv catheters' had needles that wouldn't retract and their hubs wouldn't thread during use.Lot # 8212900 was reported to have had 2 occurrences of this event, and lot# 8127892 was reported to have had 1 occurrence.
Additional Manufacturer Narrative
During dhr review: all challenge, set-up and in process inspections were performed per control plan and all passed per specifications.No qns were initiated during production.Received a total of 3 units as follows: unit 1 ¿ a fully retracted needle-barrel assembly and a catheter-adapter assembly within an open package from lot: 8127892 unit 2 ¿ a fully retracted needle-barrel assembly and a catheter-adapter assembly within an open package from lot: 8212900.Unit 3 ¿ a fully retracted needle-barrel assembly within an open package from lot number: 8212900.Visual examination: the catheter tips were acceptable per specifications and no evident damage was found on the catheter tubing.The needles were pushed into the out position and the needle tips were acceptable per specifications and no damage was found on the cannula.The needles successfully retracted upon pressing the white button.No physical-mechanical damage was observed on any of the components of the units received and no manufacturing related issues that would trigger the failure experienced by the customer was found.
Event or Problem Description
It was reported that 3 of the bd insyte¿ autoguard¿ shielded iv catheters' had needles that wouldn't retract and their hubs wouldn't thread during use.Lot #: 8212900 was reported to have had 2 occurrences of this event and lot#: 8127892 was reported to have had 1 occurrence.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8351493
• Report Number: 1710034-2019-00187
• Device Sequence Number: 16716333
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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 Catalogue Number: 381467
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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