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

Catalog Number 10802688

Device Problem Material Separation (1562)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ smartsite¿ gravity set tubing broke off below the drip chamber while being primed.The following information was provided by the initial reporter: "bd smartsite gravity set broke off when connected to iv fluid and primed.Tubing broke off just below the drip chamber.".

Event Description

It was reported that the bd alaris¿ smartsite¿ gravity set tubing broke off below the drip chamber while being primed.The following information was provided by the initial reporter: "bd smartsite gravity set broke off when connected to iv fluid and primed.Tubing broke off just below the drip chamber.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-feb-2023.H6: investigation summary one sample was received and tested by our quality team.The separation was immediately noticed and the complaint of drip chamber separation was verified.The tubing was analyzed under microscope and there was a clear lack of solvent where it was to be inserted into the drip chamber.The root cause is due to an improper use of assembly equipment to apply solvent to tubing.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16382747
• MDR Text Key: 309640456
• Report Number: 9616066-2023-00213
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: 10885403234439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10802688
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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