MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Model Number	382537
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
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.(b)(4).
Event or Problem Description
It was reported that the insyte autog bc pnk 20ga x 1.88in needle would not retract from the patient.The following information was provided by the initial reporter: "after inserting the iv picc nurse was unable to retract the needle from patient.".
Event or Problem Description
It was reported that the insyte autog bc pnk 20ga x 1.88in needle would not retract from the patient.The following information was provided by the initial reporter: "after inserting the iv picc nurse was unable to retract the needle from patient.".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received one partially retracted unit.Upon inspection of received unit it was noted that the button has been pressed and the unit is partially retracted.It was found that the base of the hub has been caught on a lip created at the connection between the grip and barrel.Based on the shape and location of the damage it can be concluded that the defect most likely originated during the manufacturing process.Misalignment of the probe or unit while inserting the plug may result in damage to the grip creating the warped effect observed on the unit.Inspections are performed during setup and periodically during manufacturing per the sampling plan to mitigate and detect the occurrence of this defect.Preventative maintenance of the load plug and inspect plug station was verified to be up to date during the manufacturing of this lot.The reported issue was confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: INSYTE AUTOG BC PNK 20GA X 1.88IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11248868
• Report Number: 1710034-2021-00066
• Device Sequence Number: 3111154
• Product Code: FOZ
• UDI-Device Identifier: 30382903825371
• UDI-Public: 30382903825371
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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 Expiration Date: 05/31/2023
• Device Model Number: 382537
• Device Catalogue Number: 382537
• Device Lot Number: 0169618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1