MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. MCKESSON PREVENT® R SHIELDED IV CATHETERS; INTRAVASCULAR CATHETER

Model Number	192-PB20116
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using mckesson prevent® r shielded iv catheters the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: needle not retracting when button is pushed.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Lot# 183216 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.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 while using mckesson prevent® r shielded iv catheters the needle failed to retract.There was no report of patient impact.The following information was provided by the initial reporter: needle not retracting when button is pushed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 25-apr-2022.Investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received five unopened units from lot number 0183216.To inspect for retraction failure the device will be visually inspected for any visible defects.This includes bound springs, excess gel, and more.There were no defects observed upon visual inspection of the device.The devices were then tested for retraction by pressing the button.All four units retracted with no defects identified.As the device retracted and no defects were observed in the returned units the defect cannot be confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

• Brand Name: MCKESSON PREVENT® R SHIELDED IV CATHETERS
• 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: 14112581
• Report Number: 1710034-2022-00185
• Device Sequence Number: 2121607
• Product Code: FOZ
• UDI-Device Identifier: 10612479250007
• UDI-Public: 10612479250007
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• 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
• Report Date (Section B): 04/26/2022

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 Model Number: 192-PB20116
• Device Catalogue Number: 380234
• Device Lot Number: UNKNOWN
• 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: 03/21/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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