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

Model Number 382523

Device Problem Leak/Splash (1354)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).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 the bd insyte¿ autoguard¿ bc shielded iv catheter hub was deformed and did not lock onto the iv tubing, causing leakage from the connection.The following information was provided by the initial reporter: "regarding bd insyte autoguard bc 22 gauge 1 inch needles.Piv placed and iv catheter hub did not luer lock into iv extension tubing properly.Iv leaking at this connection site despite changing ivextension tubing.Unable to infuse medication, needed to remove iv to place another patent iv.Patient is a difficult iv start and we were unable to establish another piv at the time and patient needed to be rescheduled.".

Event Description

It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter hub was deformed and did not lock onto the iv tubing, causing leakage from the connection.The following information was provided by the initial reporter: "regarding bd insyte autoguard bc 22 gauge 1 inch needles.Piv placed and iv catheter hub did not luer lock into iv extension tubing properly.Iv leaking at this connection site despite changing ivextension tubing.Unable to infuse medication, needed to remove iv to place another patent iv.Patient is a difficult iv start and we were unable to establish another piv at the time and patient needed to be rescheduled.".

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12713023
• MDR Text Key: 285428736
• Report Number: 1710034-2021-00924
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825234
• UDI-Public: 30382903825234
• 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,Followup
• Report Date: 11/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 1061875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic