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

Model Number	381544
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter cannula came apart during the night and remained in the patient.The following information was provided by the initial reporter: "during the night a cannula from an iv catheter came apart and the plastic cannula was left in the patient.".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photograph for evaluation.Bd received one photograph which displayed a used 18ga bd insyte autoguard winged iv catheter unit.The unit was in 2 portions.Portion 1 is the winged adapter that has traces of thick media and portion 2 is the needle/hub assembly that is fully retracted within the safety shield (barrel).In the photo is a vacutainer holder with traces of media and a hand written note with lot # 9241791.The photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.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.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter cannula came apart during the night and remained in the patient.The following information was provided by the initial reporter: "during the night a cannula from an iv catheter came apart and the plastic cannula was left in the patient.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9662642
• Report Number: 1710034-2020-00048
• Device Sequence Number: 10934814
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 381544
• Device Catalogue Number: 381544
• Device Lot Number: 9241791
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other