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

Model Number	381444
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insyte autoguard straight leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we had a compass report for a product failure of bd insyte autogaurd 18ga x1.16.Please see details below.Brief factual description 18 gauge bd insyte autoguard iv vatheter lot 0286273 when rn started iv and pushed the needle retractor button, blood gushed out of iv.Usually there is a seal that prevents the bleeding from occuring.This has happened with other rns on the night shift per report.Cs responded on 3/30; ¿ can you confirm how many occurrences of this issue? are dates of the events available? unsure of how many occurrences.The l&d staff tell me there have been ¿several.¿ no dates available.Was there any patient harm or adverse or adverse events? no.If so, was any medical intervention required? what was done & what was outcome? n/a.If applicable, are any patient identifiers available? no.Are any photos or samples available? & are they contaminated? please confirm address of facility if available.No (b)(6) 2023 customer response (see attached email) "basically when the device retracted, blood leaked".
Event or Problem Description
It was reported while using bd insyte autoguard straight leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we had a compass report for a product failure of bd insyte autogaurd 18ga x1.16.Please see details below.Brief factual description 18 gauge bd insyte autoguard iv vatheter lot 0286273 when rn started iv and pushed the needle retractor button, blood gushed out of iv.Usually there is a seal that prevents the bleeding from occuring.This has happened with other rns on the night shift per report.Cs responded on 3/30; can you confirm how many occurrences of this issue? are dates of the events available? unsure of how many occurrences.The l&d staff tell me there have been ¿several.¿ no dates available.Was there any patient harm or adverse or adverse events? no.If so, was any medical intervention required? what was done & what was outcome? n/a if applicable, are any patient identifiers available? no.Are any photos or samples available? & are they contaminated? please confirm address of facility if available.No.07apr2023 customer response (see attached email) "basically when the device retracted, blood leaked.".
Additional 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 STRAIGHT
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16731734
• Report Number: 1710034-2023-00414
• Device Sequence Number: 15119186
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: (01)30382903814443
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2023

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 381444
• Device Catalogue Number: 381444
• Device Lot Number: 0286273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 05/07/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown