MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC WING; PERIPHERAL IV CATHETERS

Catalog Number	382512
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autog bc wing blood control did not work.The following information was provided by the initial reporter: blood control value of the iv didnt work upon insertion query response: ¿ please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.This information is unavailable.¿ when did the incident occur? approximately 2-3 weeks ago.¿ how was treatment completed for customer? iv stick (primary) was a ¿miss.¿ second iv was placed without incident.¿ describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.Second iv was placed without incident.No harm to patient.Bc function worked properly.¿ please confirm whether there was any patient impact.N/a ¿ can you please provide more details and describe how the product is damaged.A blood control iv was purchased.Upon use of the iv it was noted that the bc either did not function properly, or was missing from this unit.
Additional Manufacturer Narrative
Correction: lot number was confirmed and added into tab d.Additional information added to tab b.
Event or Problem Description
(b)(6) 2024 customer response additional information received: yes, hcp unexpectantly had exposure to blood.Yes, on all occasions, hcp were wearing ppe.When the needle retracted, the iv started dripping blood down the patients arms and onto the gloved hands of the hcp.The exposure did require medical intervention by hcp to stop the flow of the blood from the patient and in some cases, the iv needed to be restarted.Hcp did not require medical intervention.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
Please provide lot number.Two events occurred same date? it is stated "hcp was exposed to blood unexpectedly." was the hcp wearing ppe? please describe the exposure referenced.Did this exposure require medical intervention? if yes, describe.#1.There are 3 lot #'s in question: 3055272 3278270 3153587.There are 2 different product #'s in question: 382512 382612 #2.The multiple events occurred on different days.( i have included the wrappers for each.) all product were supposed to have "bc" technology.) #3.Yes, hcp unexpectedly had exposure to blood.#4.Yes, on all occasions, hcp were wearing ppe.#5.When the needle retracted, the iv started dripping blood down the patients arms and onto the gloved hands of the hcp.#6.The exposure did require medical intervention by hcp to stop the flow of the blood from the patient and in some cases, the iv needed to be restarted.Hcp did not require medical intervention.

• Brand Name: BD INSYTE AUTOG BC WING
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18887440
• Report Number: 1710034-2024-00174
• Device Sequence Number: 7774093
• Product Code: FOZ
• UDI-Device Identifier: 00382903826124
• UDI-Public: (01)00382903826124(11)230602(17)260531(10)3055272
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

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: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 382512
• Device Lot Number: 3055272
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 09/19/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 03/15/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown