MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD; INTERVASCULAR CATHETER

Catalog Number 381433

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Phlebitis (2004); Thrombosis (2100)

Event Date 02/07/2019

Event Type  malfunction  

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.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.

Event Description

It has been reported that one 20g x 1.00in (1.1 x 25 mm) insyte autoguard has been found causing an allergic reaction during use.The following has been provided by the initial reporter: material no.381433, batch no.Unknown.It was reported that health professional stated that facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6).Verbatim: 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.Inserted and removed (b)(6) 2019.By the time they noticed an issue they weren't recording lot numbers.

• Brand Name: 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD
• Type of Device: INTERVASCULAR 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: 8847946
• MDR Text Key: 153859397
• Report Number: 1710034-2019-00824
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814337
• UDI-Public: 30382903814337
• 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: 07/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Sequence Number: 1
• Patient Outcome(s): Other