MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN INSYTE¿ AUTOGUARD¿; INTRAVENOUS CATHETER

Catalog Number 381523

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during use of the 22 g x 1.00 in insyte¿ autoguard¿ the catheter had a hole in it causing blood to come out onto patient.There was no report of injury or medical intervention.

Manufacturer Narrative

Lot analysis: device/batch history record review: yes.Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).Findings: as this complaint was a mdr; -dhr review was performed on the following lot number: 6307826 ¿ the lot number was built on afa line 5, from november 9, 2016 thru november 15, 2016.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification 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.In process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Visual analysis: observations and testing: received one used iag 22ga unit with an open package from the lot number 6307826.The unit consisted if the retracted needle/barrel assembly and the catheter/adapter assembly.Visual/microscopic examination: observed there was characteristic v shape (cut) of a spear thru in the catheter tubing approximately ¼ of an inch above the nose of the adapter.Water/air leak test: using a lab supplied male slip luer test fitting and the returned extension set performed the leak test.Observed there was no leakage in any are of the connection site.Leakage was observed in the area of the v shape cut.Investigation samples(s) meet manufacturing specifications: no; the returned unit provided for evaluation revealed the character v shape of a spear thru; which did leaked when tested.Comment: it is uncertain whether the defect of needle thru catheter which was observed was caused by manipulation of the device by the user or by the manufacturing process.The unit was returned used, retracted and with an opened package.

• Brand Name: 22 G X 1.00 IN INSYTE¿ AUTOGUARD¿
• 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: 6966931
• MDR Text Key: 90770215
• Report Number: 1710034-2017-00268
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903815235
• UDI-Public: 30382903815235
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 381523
• Device Lot Number: 6307826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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