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

Model Number 20039E

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21055698.Medical device expiration date: 2024-05-13.Device manufacture date: 2021-05-07.Medical device lot #: 21055608.Medical device expiration date: 2024-05-13.Device manufacture date: 2021-05-06.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd alaris¿ smartsite¿ extension set each from lots 21055698 and 21055608 had flow issues and were blocked during use.The following information was provided by the initial reporter: "it was reported by the customer that the product does not allow to flush or pull back." "no adverse events first time occurred 8/23 it happened on 8/26 with the following 2 lots as well.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the product does not allow to flush or pull back.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 20039e lot number 21055698 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20039e lot number 21055608 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #21055698 regarding item #20039e.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #21055608 regarding item #20039e.

Event Description

It was reported that 1 bd alaris¿ smartsite¿ extension set each from lots 21055698 and 21055608 had flow issues and were blocked during use.The following information was provided by the initial reporter: "it was reported by the customer that the product does not allow to flush or pull back." "no adverse events first time occurred 8/23 it happened on 8/26 with the following 2 lots as well.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12520215
• MDR Text Key: 272950904
• Report Number: 9616066-2021-52118
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013820
• UDI-Public: 27613203013820
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1