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

Catalog Number	42103E-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 the bd alaris¿ smartsite¿ gravity set tubing separated from the drip chamber while spiking the iv bag.This occurred with 3 different sets.The following information was provided by the initial reporter: "bd smartsite gravity iv sets have separated at top where drip chamber meets tubing.The tubing literally separates when trying to spike an iv bag.It does not seem as though the two pieces are sealed together, because the separation is clean.This must be an infection control issue.Bd iv tubing disconnecting/separating below the drip chamber.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02-feb-2023.H6: investigation summary the customer reported separation at the drip chamber and returned 4 sets.The first three were all separated at the drip chamber (3 sets, 2 chambers returned) and the fourth set was separated at the inlet of first smart site.Complaint verified.The root cause is traced to insufficient solvent for all 4 failures, which is related to manufacturing process.Device history record review for model 42103e lot number 22049268 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ gravity set tubing separated from the drip chamber while spiking the iv bag.This occurred with 3 different sets.The following information was provided by the initial reporter: "bd smartsite gravity iv sets have separated at top where drip chamber meets tubing.The tubing literally separates when trying to spike an iv bag.It does not seem as though the two pieces are sealed together, because the separation is clean.This must be an infection control issue.Bd iv tubing disconnecting/separating below the drip chamber.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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 ; 8015296192
• MDR Report Key: 16318803
• Report Number: 9616066-2023-00159
• Device Sequence Number: 18288332
• Product Code: FPA
• UDI-Device Identifier: 10885403225840
• UDI-Public: 10885403225840
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 02/15/2023

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 Expiration Date: 04/25/2025
• Device Catalogue Number: 42103E-07
• Device Lot Number: 22049268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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