MAUDE Adverse Event Report: TELEFLEX MEDICAL DEBAKEY HEPARIN NEEDLE SMALL; CANNULA, SURGICAL, GENERAL & P

Model Number	IPN005374
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: the device snapped/broke in two pieces where the needle and hub connect, during use.The patient was undergoing an extended hysterectomy.No patient injury.
Event or Problem Description
Reported issue: the device snapped/broke in two pieces where the needle and hub connect, during use.The patient was undergoing an extended hysterectomy.No patient injury.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the device was broken at the welded union.Visual review of break suggests that the break happened in a single event and no signs of alteration of the shaft were evident.The root cause of the breakage could not be established.

• Brand Name: DEBAKEY HEPARIN NEEDLE SMALL
• Common Device Name: CANNULA, SURGICAL, GENERAL & P
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16615117
• Report Number: 3011137372-2023-00055
• Device Sequence Number: 12299403
• Product Code: GEA
• UDI-Device Identifier: 24026704517200
• UDI-Public: 24026704517200
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

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: Health Professional
• Device Model Number: IPN005374
• Device Catalogue Number: 351575
• Device Lot Number: W1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Age: 46 YR
• Patient Sex: Female