MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ COMBINATION EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	20511E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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 the bd alaris¿ smartsite¿ combination extension set was blocked/occluded at the lower y-site port.The following information was provided by the initial reporter: "anesthesiologist, told me she had a 20511e set where the lower y-site port would not flow.She had an me2010 syringe tubing attached to the port and it would not flow.She tried taking it off, and trying a stopcock on it and it still would not slow.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ combination extension set was blocked/occluded at the lower y-site port.The following information was provided by the initial reporter: "anesthesiologist, told me she had a 20511e set where the lower y-site port would not flow.She had an me2010 syringe tubing attached to the port and it would not flow.She tried taking it off, and trying a stopcock on it and it still would not slow.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the lower y-site port would not flow.The customer complaint 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 20511e because a lot number was not provided by the customer.A definitive root cause for the customer's experience could not be determined as no needle-free connector (smartsite) was returned.Capa#1998036 was initiated.H3 other text : see h.10.

• Brand Name: BD ALARIS¿ SMARTSITE¿ COMBINATION EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12482141
• Report Number: 9616066-2021-52057
• Device Sequence Number: 19766949
• Product Code: FPA
• UDI-Device Identifier: 50885403234932
• UDI-Public: 50885403234932
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 10/07/2021

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: Health Professional
• Device Model Number: 20511E
• Device Catalogue Number: 20511E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 60 IN NON-DEHP MINIBORE EXTENSION SET