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

Catalog Number 381834

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter separated from needle during use.No serious injury or medical intervention was reported.Verbatim: "needle separates from catheter during use.Additional information from the customer: the device was used to prick a patient, the needle is retracted into the sleeve provided for this purpose; the needle detached from the catheter when the nurse uncapped the device; the catheter was stuck in the cap.".

Manufacturer Narrative

The following field was updated due to corrected information: describe event or problem: it was reported that bd insyte¿ autoguard¿ shielded iv catheter separated from needle during use.No serious injury or medical intervention was reported.Verbatim: "needle separates from catheter during use.Additional information from the customer: the device was used to prick a patient, the needle is retracted into the sleeve provided for this purpose; the needle detached from the catheter when the nurse uncapped the device; the catheter was stuck in the cap." investigation: during dhr review all challenge, set up and in process samples were performed according to the control plans.No qns were initiated during the production.Received a 20ga iag unit within an open package from lot number 8267564.The needle was received fully retracted inside the barrel.Visual/microscopic examination: upon removing the needle cover to examine the unit the catheter adapter assembly stayed lodged within the needle cover.The catheter-adapter assembly was incorrectly oriented within the needle cover.Since the unit was received out of its original package, we were unable to confirm whether the cover or the catheter/adapter were manipulated prior to use (user environment) or was caused by mis-orientation (manufacturing).

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter separated from needle during use.No serious injury or medical intervention was reported.Verbatim: "needle separates from catheter during use.Additional information from the customer: the device was used to prick a patient, the needle is retracted into the sleeve provided for this purpose; the needle detached from the catheter when the nurse uncapped the device; the catheter was stuck in the cap.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8387850
• MDR Text Key: 137969989
• Report Number: 1710034-2019-00244
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818341
• UDI-Public: 00382903818341
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 381834
• Device Lot Number: 8267564
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other