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

Model Number 381423

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that while using 3 bd insyte¿ autoguard¿ shielded iv catheter the catheter hub would not retract.Patients had to be re-stuck.The following information was provided by the initial reporter: hoping you can help me with this issue¿we've had three incidents occur when using the bd insyte autoguard 22g iv catheters (ref (b)(4).The catheter hub is unable to be detached.Even pressing the release button does not retract the needle because the hub is stuck.Unfortunately we had to remove it entirely and stick the patients again when this happened.

Event Description

It was reported that while using 3 bd insyte¿ autoguard¿ shielded iv catheter the catheter hub would not retract.Patients had to be re-stuck.The following information was provided by the initial reporter: hoping you can help me with this issue¿we've had three incidents occur when using the bd insyte autoguard 22g iv catheters (ref (b)(4)).The catheter hub is unable to be detached.Even pressing the release button does not retract the needle because the hub is stuck.Unfortunately we had to remove it entirely and stick the patients again when this happened.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/2/2021.H.6.Investigation: our quality engineer inspected the representative samples submitted for evaluation.Bd received 28 sealed 22ga insyte autoguard units from lot number 1179070.A gross visual inspection of the returned units did not find any damage to the components.All units were functionally tested for needle retraction failure, and they successfully retracted.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in the report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12801679
• MDR Text Key: 280948675
• Report Number: 1710034-2021-00981
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814237
• UDI-Public: 00382903814237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• 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,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 1179070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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