MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381467

Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation: investigation summary: review of the dhr revealed 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.Received one unused iag 14ga unit in sealed package from the lot number 6308948.Visual/microscopic examination: observed there was no mechanical/physical damage to any of the components (spring, needle, hub, or grip) or evidence of adhesive on the button or hub.Functional test (needle retraction) was performed: performed the hub twist test then depressed the button.The retraction was successful, no delayed reaction was observed.The returned unit provided for evaluation met and performed per the required manufacturing specifications.Investigation conclusion: the defect needle retraction failure as stated in the description of the complaint was not confirmed with the returned unit.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the incident report could not be confirmed or replicated with the returned units.The actual unit described in the incident report was not returned for evaluation.The customer experience was not confirmed based on the evaluation and testing that was performed on the returned unit.Reproduction of the customer¿s experience was not achieved with the testing performed on the returned unit.Root cause description: there was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident.

Event Description

It was reported that the needle on a bd insyte¿ autoguard¿ shielded iv catheter failed retract after use.No injury or medical intervention.

• Brand Name: 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: 7148455
• MDR Text Key: 95934025
• Report Number: 1710034-2017-00484
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 381467
• Device Lot Number: 6308948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• 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