MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE LOW SORBING EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20350E-0006

Device Problem Obstruction of Flow (2423)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 bd alaris smartsite low sorbing extension set was occluded.The following information was received by the initial reporter with the verbatim: email received for customer informing bd of ?: faulty product as unable to prime extension set beyond filter.Customer reports that the acc dept has been using this filter set for years and it is both experienced and junior staff reporting the issues, so far nothing user error-related that they can see.Please see email for further information pir logged.

Manufacturer Narrative

D4: second lot number not included in initial submission, catalog #: 20350e-0006, lot #: 22119044, expiration date: 11/03/2025, manufacturing date: 11/18/2022.Investigation results: four 20350e-0006 samples were received for investigation; three samples were received in opened packaging from lot 22119318, and one sample was received in opened packaging from lot 22119044.Each of the sets were subjected to functional testing by attempting to prime the extension set; in three of the sets the customer's experience was confirmed with no fluid able to travel beyond the filter component (appendix 1-3).However in one the samples no fluid blockage or flow restriction was observed throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the blockage was likely caused by an excess of solvent having been applied at the tubing joint of the filter during manufacture.This is a hand assembled joint and is likely to have occurred due to human error.A review of the production records for lot 22119318 & 22119044 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20350e-0006 set in the past 12 months.

Event Description

No additional information.It was reported that bd alaris smartsite low sorbing extension set was occluded.The following information was received by the initial reporter with the verbatim: email received for customer informing bd of faulty product as unable to prime extension set beyond filter.Customer reports that the acc dept has been using this filter set for years and it is both experienced and junior staff reporting the issues, so far nothing user error-related that they can see.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18081165
• MDR Text Key: 327611003
• Report Number: 9616066-2023-02151
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020085
• UDI-Public: (01)37613203020085
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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
• Device Operator: Other
• Device Catalogue Number: 20350E-0006
• Device Lot Number: 22119318
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1