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

Catalog Number	381437
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ shielded iv catheter needle would not retract.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-dec-2022.Our quality engineer inspected the sample submitted for evaluation.Bd received one used 20g x 1.88in.Insyte autoguard unit from lot number 1300906.A gross visual inspection of the returned unit found that the needle was in the un-retracted position and the button had not been depressed.The catheter assembly was not returned.Further microscopic inspection found adhesive between the needle hub and grip which prevented needle retraction.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the adhesive dispensing station.This may occur at the adhesive dispense process due to station misalignment, part misalignment or adhesive buildup on the nozzle.Per our quality control plan, inspections for needle retraction and excessive adhesive are performed periodically during the manufacturing process to mitigate the occurrence of this defect.Preventative maintenance (pm¿s) is performed to maintain and ensure proper functioning of equipment.Pm records were verified to be up to date during the production of this lot.In addition, a device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle would not retract.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have had 2 instances where the above needle did not retract.".

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• 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: 15643237
• Report Number: 1710034-2022-00612
• Device Sequence Number: 6224628
• Product Code: FOZ
• UDI-Device Identifier: 00382903814374
• UDI-Public: (01)00382903814374
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2023

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: 381437
• Device Lot Number: 1300906
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/29/2022; 01/09/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/07/2022; 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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