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

Model Number 382634

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer: bd was initially made aware of this complaint on 2020-10-16.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2020-12-09 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.(b)(4).Investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received three photos with one photo displaying two used units with media present.The defect "activated in package" as stated as a reported defect was not confirmed based on the evidence of media throughout the units indicating that venipuncture occurred which would not be possible if the unit was already retracted.Further visual examination of the photos revealed that one of the units had a significant amount of media buildup while there was a lack of blood near the grip indicating that leakage occurred.Without the physical sample, a definite cause could not be established.A device history record review showed no non-conformances associated with this issue during the production of this batch.Investigation conclusion: root cause description: the leakage most likely occurred due to a damage vent plug or hub.As the components are very unlikely to be damaged by the customer due to their location the defect is most likely to have occurred during manufacturing, however it cannot be confirmed with certainty without close examination of a physical sample.Rationale: customer complaint trends are evaluated on a monthly basis and currently do not indicate the need for a formal corrective action.However, a notification of awareness has been sent to the manufacturing department.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd insyte" autoguard" bc shielded iv catheter leaked.The following information was provided by the initial reporter: "damaged or activated in package" "further visual examination of the photos revealed that one of the units had a significant amount of media buildup while there was a lack of blood near the grip indicating that leakage occurred.".

• Brand Name: 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 ; 8015296192
• MDR Report Key: 11083587
• MDR Text Key: 226049232
• Report Number: 1710034-2020-00830
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826347
• UDI-Public: 30382903826347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 382634
• Device Catalogue Number: 382634
• Device Lot Number: 0119493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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