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

Catalog Number	381923
Medical Device Problem Codes	Retraction Problem (1536); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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 autoguard winged needle retraction button did not depress.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about safety mechanism push button cannot be pressed during use.Customer reported that when placing an indwelling needle in a patient, the push button was stiff and i couldn't press it.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: received one unsealed 22ga x 1.00in.Insyte autoguard winged unit from lot: 3321581.Additionally, 5 photos were provided.A gross visual inspection was performed on the provided unit and adhesive was discovered.Microscopic analysis discovered the adhesive poured between the needle hub and the grip, preventing the needle from retracting.The button was unable to be activated so the adhesive may also have poured on the inside of the button.The reported defect was confirmed.During manufacturing, adhesive is dispensed into the hub to secure the cannula.Station misalignment may cause the adhesive to pour on the outside of the hub which can then flow in between the needle hub and the grip or the button.This may cause partial/slow/ or no retraction.A vision system software is in place to mitigate the occurrence of this defect.A trend was identified for needle retraction failure complaints and corrective actions were implemented to address this issue.The implicated lot was manufactured after the implementation dates.This complaint type and corrective action will continue to be monitored for effectiveness.A notification of awareness has been sent to the manufacturing department.Investigation conclusion(s): the defect of ¿needle retraction failure¿ was confirmed.Probable root cause(s): manufacturing.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• Common Device Name: PERIPHERAL IV 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19004131
• Report Number: 1710034-2024-00262
• Device Sequence Number: 9429488
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: Other
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 381923
• Device Lot Number: 3321581
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown