MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC, 20G X 1.16 IN.; INTRAVENOUS CATHETER

Catalog Number 381034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Phlebitis (2004)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation: result - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5062943.Two representative units in sealed packaging from the lot number 5062943 were received.Package leak testing was performed using a lab supplied iso 22ga needle/hub assembly attached to the male luer fitting of the station.The leak test was performed by submerging the packages beneath the water line; piecing the needle/hub into the cavity; many bubbles were released from many locations of the package.There were no gross leaks or opened seals.A visual/microscopic examination was performed and there was no foreign matter observed on any the units.The bevel area had the proper bevel cut and the secondary bevel was present.The lie distance was within acceptable range.The cannula tip quality was found to be acceptable.No bends holes, kinks splits or wrinkles were found in the catheter tubing.The catheter tip quality was found to be acceptable.The representative units tested met all specification requirements.The finished product testing report was reviewed and all pallets passed.The pyrogen samples also passed all testing.Conclusions - the defect was not confirmed.There was no physical evidence to confirm or to support manufacturing process related issues for the defect.The returned units did not display any adverse characteristics that would contribute to the defect the customer complained about.The defects described in the incident report could not be confirmed or replicated with the returned units.

Event Description

It was reported that in recent weeks, the pneumology department noticed an increase in the appearance of thrombophlebitis from the suspect device.Echo doppler was performed to refine the diagnosis.The patient experienced significant pain and was provided anticoagulant treatment.Another department was contacted and it was reported that they were also experiencing thrombophlebitis.No additional specific patient information was provided, including the number of patients involved.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC, 20G X 1.16 IN.
• Type of Device: INTRAVENOUS 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 ; 8015652845
• MDR Report Key: 5345664
• MDR Text Key: 35164940
• Report Number: 1710034-2016-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2016

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?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 381034
• Device Lot Number: 5062943
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention