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

Catalog Number	72215N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ secondary set tubing fell off the bottom of the drip chamber when the penicillin secondary infusion was started.The following information was provided by the initial reporter: "after the rn began the secondary infusion, she was putting a sticker on the drip chamber and the tubing fell off of the bottom of the drip chamber.The medication had just been started, so it had not reached the patient.A new set of secondary tubing and a new dose of medication was obtained and started with no issues.What was the original intended procedure? pt was to be given a dose of penicillin as a secondary infusion".
Additional Manufacturer Narrative
The initial reporter also notified the fda medwatch report # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 07-feb-2023.H6: investigation summary: the customer reported the drip chamber fell off right after medication was started.The sample was returned and the separation was verified.The root cause was found to be insufficient solvent applied during assembly process on the tubing.Device history record review for model 72215n lot number 22059310 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¿ secondary set tubing fell off the bottom of the drip chamber when the penicillin secondary infusion was started.The following information was provided by the initial reporter: "after the rn began the secondary infusion, she was putting a sticker on the drip chamber and the tubing fell off of the bottom of the drip chamber.The medication had just been started, so it had not reached the patient.A new set of secondary tubing and a new dose of medication was obtained and started with no issues.What was the original intended procedure? : pt was to be given a dose of penicillin as a secondary infusion".

• Brand Name: BD ALARIS¿ SECONDARY 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: 16251583
• Report Number: 9616066-2023-00096
• Device Sequence Number: 5490476
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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: Health Professional
• Device Expiration Date: 05/20/2025
• Device Catalogue Number: 72215N
• Device Lot Number: 22059310
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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