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

Catalog Number 381923

Device Problems Retraction Problem (1536); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

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 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 Description

No additional information.

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
• Type of Device: 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
• MDR Text Key: 339912706
• Report Number: 1710034-2024-00262
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 381923
• Device Lot Number: 3321581
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1