MAUDE Adverse Event Report: 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	30263E
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 at least one 40 inch ext w/2 vlv port experienced a missing component.The following information was provided by the initial reporter: caller states part number 20028e used to have a swivel on one side and no longer has a swivel.Caller wants to know if there has been a change to the product.Caller states product 30263e has a similar construct.Caller states they have many of these products and had this issue a few months ago.
Additional Manufacturer Narrative
The following fields were updated due to corrected information: h.6.Investigation: no product or photo was returned by the customer.The customer complaint of misassembly - other missing component could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 30263e because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that at least one 40 inch ext w/2 vlv port experienced a missing component.The following information was provided by the initial reporter: caller states part number 20028e used to have a swivel on one side and no longer has a swivel.Caller wants to know if there has been a change to the product.Caller states product 30263e has a similar construct.Caller states they have many of these products and had this issue a few months ago.

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12191711
• Report Number: 9616066-2021-51553
• Device Sequence Number: 3441667
• Product Code: FPA
• UDI-Device Identifier: 50885403235205
• UDI-Public: 50885403235205
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 08/05/2021

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: 30263E
• Device Catalogue Number: 30263E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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