MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

Catalog Number	382944
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology needle would not retract after the insertion as the safety mechanism malfunctioned.The following information was provided by the initial reporter, translated from (b)(6): "when the catheter was inserted, the spring did not engage properly when the catheter was retracted.This prevented the catheter from being changed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology needle would not retract after the insertion as the safety mechanism malfunctioned.The following information was provided by the initial reporter, translated from french: "when the catheter was inserted, the spring did not engage properly when the catheter was retracted.This prevented the catheter from being changed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 14-oct-2022 h6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one used 18g x 1.16in.Insyte autoguard bc pro winged needle assembly from lot number 1322454.The needle was already retracted upon receipt.The unit was microscopically inspected for damage to the components or excess adhesive, all of which are known to cause retraction failure.No abnormalities were found.The unit was then un-retracted to attempt to replicate the reported event.The amount of dried blood inside the needle assembly, however, prevented the needle from being fully un-retracted.Therefore, the unit was first rinsed multiple times with water to remove some of the dried blood.The unit was then un-retracted and successfully retracted without issue.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.The returned unit provided for evaluation met and performed per the required manufacturing specifications.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• Common Device Name: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15488914
• Report Number: 1710034-2022-00544
• Device Sequence Number: 1885796
• Product Code: FOZ
• UDI-Device Identifier: 00382903829446
• UDI-Public: (01)00382903829446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 10/31/2024
• Device Catalogue Number: 382944
• Device Lot Number: 1322454
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown