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

Catalog Number	20029E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately 10 bd alaris¿ smartsite¿ extension sets leaked at the edge of the filter during use.The following information was provided by the initial reporter: "verbatim: 1.The db maxzero (mz9270) microbore tri-fuse extension set 3 iv, filter set.A.Approx 10 sets so far have been found leaking.These sets are leaking at the filter, it appears to be a slow oozing leak.B.Not the hubs but at the filter.We just had another triple connector start leaking on a micro preemie (1200 grams).This is a huge issue as our babies are not only missing out on nutrition, this greatly increases the risk for infection in these immune compromised infants.It is not clogging; the area is leaking at the edge of the filter.The tri connectors are changed daily.Seems to be happening soon after the tpn change.".
Additional Manufacturer Narrative
D.4.The reported lots 22119145 and 23029243 were not found for the reported catalog# 20029e.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that approximately 10 bd alaris¿ smartsite¿ extension sets leaked at the edge of the filter during use.The following information was provided by the initial reporter: " the db maxzero (mz9270) microbore tri-fuse extension set 3 iv, filter set.Approx 10 sets so far have been found leaking.These sets are leaking at the filter, it appears to be a slow oozing leak.Not the hubs but at the filter.We just had another triple connector start leaking on a micro preemie (1200 grams).This is a huge issue as our babies are not only missing out on nutrition, this greatly increases the risk for infection in these immune compromised infants.It is not clogging; the area is leaking at the edge of the filter.The tri connectors are changed daily.Seems to be happening soon after the tpn change.".
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the previously submitted report 9616066-2023-00942 was sent in error.This was not a complaint but a question.Mfr#: 9616066-2023-00942 is void as a result.Mdr# 9616066-2023-00961 is the report for the leakage mentioned.

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16959333
• Report Number: 9616066-2023-00942
• Device Sequence Number: 20206552
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/13/2023

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
• Operator of Device: Other
• Device Catalogue Number: 20029E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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
• Patient Sex: Unknown