MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC WING; PERIPHERAL IV CATHETERS

Catalog Number	382633
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autog bc wing needle is slow to retract.The following information was provided by the initial reporter: one of the ivs would not deploy and the other had a defective safety mechanism.They have seen several of these incidents with the two lots noted.The nurse supervisor informed me that the ed nurses were having trouble with these 20ga.Iv catheters.When they push the white button on the catheter it is having a slow delay on retracting.When normally it retracts quickly.No injury reported, only multiple stick required.
Additional Manufacturer Narrative
This mdr is a result of an investigation finding that resulted in identification of a slow needle retraction.Investigation: our quality engineer inspected the representative samples submitted for evaluation.Bd received (b)(4).Sealed 20ga x 1.00in.Insyte autoguard bc winged units from lot number 4222721 and 46 sealed units from lot number 4123611.A sampling of 20 units from lot number 4123611 were randomly selected for testing of threading difficulties.All units past inspection and no damages to the threading or issues when advancing the catheter were discovered, however a slow retraction was observed.A sampling of (b)(4).Units from lot number 4222721 were randomly selected for functional testing.The (b)(4).Sealed units were tested by breaking tip adhesion, slightly advancing the catheter, and then activating the button.This functional test revealed that the retraction time of some of the needles exceeded the 1.5 second specification.Your reported issue was confirmed as a slow retraction.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to excessive gel in the space between the flash chamber and the grip.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.The appropriate personnel have been notified and we appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE AUTOG BC WING
• 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: 21309563
• Report Number: 1710034-2025-00113
• Device Sequence Number: 8847735
• 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: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• 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
• Report Date (Section B): 02/03/2025

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: 4123611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/04/2025
• 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