MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO SAFETY 24GX0.75IN WINGED; INTRAVASCULAR CATHETER

Model Number	391662
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that neoflon pro safety 24gx0.75in winged needle would not retract.The following information was provided by the initial reporter: child being cannulated.Registrar removed needle from safety cannula.Needle was difficult to remove and the safety catch failed to deploy leaving needle exposed and causing doctor to sustain needle stick injury.
Event or Problem Description
It was reported that neoflon pro safety 24gx0.75in winged needle would not retract.The following information was provided by the initial reporter: child being cannulated.Registrar removed needle from safety cannula.Needle was difficult to remove and the safety catch failed to deploy leaving needle exposed and causing doctor to sustain needle stick injury.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h10.

• Brand Name: NEOFLON PRO SAFETY 24GX0.75IN WINGED
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12467880
• Report Number: 8041187-2021-00835
• Device Sequence Number: 3793909
• Product Code: FOZ
• UDI-Device Identifier: 00382903916627
• UDI-Public: 00382903916627
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201717
• 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): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 391662
• Device Catalogue Number: 391662
• Device Lot Number: 8354798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown