MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381434

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 09/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: dhr review for batch 7157626 was carried out and no related non conformances were raised in association with this packaged lot.The defect of leakage, as stated in the subject of the product incident report could not be identified or confirmed and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.Therefore, there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.This incident is indeterminate.

Event Description

It was reported that the valve on the 20 g x 1.00 in.(1.1 mm x 25 mm) bd insyte¿ autoguard¿ bc shielded iv catheter that prevents initial blood flow upon patient access is faulty and allows blood to leak out as soon as needle is retracted.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Bd awareness date was reported incorrectly.The correct awareness date was (b)(6) 2017.

• Brand Name: 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ BC 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 ; 8015652845
• MDR Report Key: 6956156
• MDR Text Key: 90635374
• Report Number: 1710034-2017-00255
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 381434
• Device Lot Number: 7157626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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