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

Catalog Number 381433

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Phlebitis (2004); Thrombosis (2100)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

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. Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place. 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 was inserted into the patient on (b)(6) 2019, resulting in "phlebitis, thrombophlebitis, or dvt" after use when the catheter was removed the next day. However, no further information was provided by the initial reporter. This complaint was created to capture the 1st of 10 related incidents. The following information was provided by the initial reporter: health professional called and stated facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6). Has the dates that patients had the iv's inserted: on (b)(6) 2019, removed (b)(6) 2019. Inserted (b)(6) 2019, removed (b)(6) 2019. On (b)(6) 2019, inserted and removed. Inserted (b)(6) 2019, removed (b)(6) 2019. On (b)(6) 2019, inserted and removed. Inserted (b)(6) 2019, removed (b)(6) 2019. Inserted and removed (b)(6) 2019. Inserted (b)(6) 2019, removed (b)(6) 2019. Inserted and removed (b)(6). Inserted (b)(6) 2019 and removed (b)(6) 2019.

• 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: 8846622
• MDR Text Key: 152920763
• Report Number: 1710034-2019-00817
• Device Sequence Number: 1
• Product Code: FOZ
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 381433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2019
• 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 Treatment Data

Date Received: 07/31/2019 Patient Sequence Number: 1