MAUDE Adverse Event Report: BD INSYTE-N¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 bd insyte-n¿ iv catheters' tips were damaged and breaking off.The following information was provided by the initial reporter: "it was reported that the clinician noticed that the plastic cannula tip appeared to be breaking off.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 bd insyte-n¿ iv catheters' tips were damaged and breaking off.The following information was provided by the initial reporter: "it was reported that the clinician noticed that the plastic cannula tip appeared to be breaking off.".

• Brand Name: BD INSYTE-N¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12314350
• Report Number: 8041187-2021-00715
• Device Sequence Number: 4672144
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: Other
• Device Model Number: 381211
• Device Catalogue Number: 381211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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