MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED; PERIPHERAL IV CATHETERS

Catalog Number	380312
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
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 autoguard wing incomplete needle retraction.The following information was provided by the initial reporter: the needle did not retract completely and was sticking out, resulting to needlestick.The employee had an er visit on the date of injury ((b)(6) 2024) with lots of labs and 4 prescriptions to take for 4 weeks for prevention of hiv and also labs to be done in 3 months, 6 months, and 1 year.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed five sealed mckesson iv safety yel wing 24ga x.75in.Units from lot number 3096297.The photos only display the top label with the product information.No units or defects are observed from the provided photos.The source of the damage could not be determined based on evaluation of the supplied photos.There was no physical evidence to conclude that the reported defect was related to the manufacturing process.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.However, a trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identity the root cause.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• 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: 20347851
• Report Number: 1710034-2024-01081
• Device Sequence Number: 8000238
• Product Code: FOZ
• UDI-Device Identifier: 20612479250226
• UDI-Public: (01)20612479250226
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 380312
• Device Lot Number: 3096297
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown