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¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381533

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: a dhr review was performed on the following lot number: 7026719 ¿ the lot number was built on afa line 6, from january 25, 2017 thru january 30, 2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications s-au33, s-au34, s-au35 and s-au36, in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Investigation samples(s) were not received for evaluation and testing.Conclusions: the defect of needle retraction failure, as stated in the subject of the pir could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing.Without a unit for evaluation; there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.Unable to reproduce the customer¿s experience because units were not returned for evaluation and testing.Root cause: without a sample for evaluation and testing, there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.(b)(4).

Event Description

It was reported that the safety on a 20 g x 1.00 in.(1.1 mm x 25 mm) bd insyte¿ autoguard¿ shielded iv catheter did not activate.No injury or medical intervention.

• Brand Name: 20 G X 1.00 IN. (1.1 MM X 25 MM) 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 ; 8015652845
• MDR Report Key: 6828453
• MDR Text Key: 84010657
• Report Number: 1710034-2017-00161
• 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
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 381533
• Device Lot Number: 7026719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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