MAUDE Adverse Event Report: BECTON DICKINSON INSYTE AUTOG BC WING PNK 20GA X 1.0IN; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	382633
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:382633.Batch#:4222721.It was reported by customer that the insyte autoguard iv catheters have been resistant to retracting using the push button technique designed.This has occurred a minimum of 9 times to the supervisor's knowledge.No employee or patient injury noted.
Additional Manufacturer Narrative
Initial mdr submission.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: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.However, the reported defect of needle retraction failure is confirmed since a trend has been identified for the reported failure mode and corrective actions have been initiated to investigate this type of incident and identify the root cause.We would be very interested in examining product that does not meet your expectations and our quality standards.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information of fa#.

• Brand Name: INSYTE AUTOG BC WING PNK 20GA X 1.0IN
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20912670
• Report Number: 1710034-2024-01477
• Device Sequence Number: 20948985
• Product Code: FOZ
• UDI-Device Identifier: 00382903826339
• UDI-Public: (01)00382903826339(11)240815(17)270731(10)4222721
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

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: 382633
• Device Lot Number: 4222721
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/28/2025; 06/13/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/04/2025; 06/17/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-25-5274
• Patient Sequence Number: 1
• Patient Sex: Female