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

Catalog Number	381923
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged needle retraction issue.The following information was provided by the initial reporter, translated from french to english: difficulty retracting the canula.Recurrent problems with several caregivers.Letter attached.Problem retracting the canula.Pressed 2 times.Repeated incidents with several ides none but risk of aes can you confirm whether samples are available for the survey? yes, 1 unit used (during or after use) important: if used, please confirm whether the samples are contaminated with blood or cytotoxic drugs.With blood.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: the complaint of slow needle retraction could not be confirmed from the returned sample.One insyte autoguard needle from lot 4222720 was provided for investigation.The needle was received fully retracted and with evidence of use.A functional test showed that the needle retracted within specification.The condition of the returned device may prevent confirmation of the reported issue.Once the needle fully retracts, the reported issue may not be possible to replicate.Although the complaint could not be confirmed, a trend was identified for needle retraction slow complaints and a capa was opened to address this issue.This complaint type and corrective action will continue to be monitored for effectiveness.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
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: 21022126
• Report Number: 1710034-2024-01537
• Device Sequence Number: 9155860
• Product Code: FOZ
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232(11)240815(17)270731(10)4222720
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 Catalogue Number: 381923
• Device Lot Number: 4222720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown