MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD WINGED YEL 24GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number 381512

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that insyte autoguard winged yel 24ga x.75in broke apart.This occurred on 64 occasions.The following information was provided by the initial reporter: material no: 381512, batch no: 0104316.It was reported breaking apart.

Event Description

It was reported that insyte autoguard winged yel 24ga x.75in broke apart.This occurred on 64 occasions.The following information was provided by the initial reporter: material no: 381512 batch no: 0104316 it was reported breaking apart.

Manufacturer Narrative

H6: investigation summary: bd received sixty-four unopened 24 gauge insyte autoguard units from lot 0104316 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed not visible damage or defects with the returned units.Next, a venipuncture test was performed and each unit was found to be within product specifications.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were found during production a definitive root cause could not be determined.H3 other text : see h10.

• Brand Name: INSYTE AUTOGUARD WINGED YEL 24GA X .75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11389233
• MDR Text Key: 233966767
• Report Number: 1710034-2021-00161
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815128
• UDI-Public: 00382903815128
• Combination Product (y/n): N
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 381512
• Device Lot Number: 0104316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1