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

Catalog Number 381434

Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.The complaint was deemed as mdr reportable therefore a submission will be performed.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.A device history record could not be completed as no lot number was received.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle retracted "slowly" during use when the button was depressed.Additionally, it was reported that another catheter needle would not retract at all after being placed in the patient's vein, and the needle could not be removed from the hub.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "when depressing the retraction button on the catheter, the needle is either slowly retracting or not retracting at all." "even had an instance yesterday where the 20 ga was inserted into the vein of a patient, blood return was noted, needle would not retract nor would the needle remove from the hub.Iv had to be removed and another one placed.".

• 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
• 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 ; 8015652341
• MDR Report Key: 9673131
• MDR Text Key: 182538122
• Report Number: 1710034-2020-00058
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: 00382903814343
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other