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

Catalog Number 41173E

Device Problem Component Missing (2306)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.H.3.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 prior to use with bd alaris¿ smartsite¿ gravity set the roll clamp was discovered to be missing.The following information was provided by the initial reporter: health professional called in to report that the product is supposed to come with roll clamp but did not have one in the package.

Event Description

It was reported that prior to use with bd alaris¿ smartsite¿ gravity set the roll clamp was discovered to be missing.The following information was provided by the initial reporter: health professional called in to report that the product is supposed to come with roll clamp but did not have one in the package.

Manufacturer Narrative

H6: investigation summary a complaint of the set missing a roller clamp was received from the customer.A photo was received for investigation.It was observed that the roller clamp was not assembled onto the set.The customer complaint was confirmed.A device history record review for model 41173e lot number 22069340 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being received, a root cause could not be determined.H3 other text : see h10.

• 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 ; 8448235433
• MDR Report Key: 17131247
• MDR Text Key: 317851575
• Report Number: 9616066-2023-01180
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 07613203020893
• 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: 06/21/2023

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: 41173E
• Device Lot Number: 22069340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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