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

Model Number 41173E

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd alaris smartsite gravity set is damaged tearing at the midline.The following information was provided by the initial reporter: gravity tubing is tearing mid line.

Event Description

It was reported that the bd alaris smartsite gravity set is damaged tearing at the midline.The following information was provided by the initial reporter: gravity tubing is tearing mid line.

Manufacturer Narrative

H6: investigation summary two photos were provided by the customer for quality investigation.One photo was of the product packaging and the second photo was of the product failure.The customer complaint of component damage - no leak was verified by photo inspection.Further examination of the photo of the failure shows that the tubing was cut.The appearance of the cut looks to have smooth edges and is on the main tubing of the infusion set.A device history record review for model 41173e lot number 23019232 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure could not be determined because a sample was not provided.

Event Description

It was reported that the bd alaris smartsite gravity set is damaged tearing at the midline.The following information was provided by the initial reporter: gravity tubing is tearing mid line.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 11-apr-2023 h6: investigation summary two photos and a sample were provided by the customer for quality investigation.One photo was of the product packaging and the second photo was of the product failure.The customer complaint of component damage - no leak was verified by evaluation of the photo received and the sample submitted.The appearance of the cut looks to have smooth edges and is on the main tubing of the infusion set.A device history record review for model 41173e lot number 23019232 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the damage seen in the sample submitted could not be determined.An investigation at the manufacturing facility was conducted and the damage seen in the sample could not be replicated by any of the manufacturing and assembly processes.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: 16562357
• MDR Text Key: 311588741
• Report Number: 9616066-2023-00473
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203020900
• UDI-Public: (01)37613203020900
• 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,Followup
• Report Date: 07/05/2023

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 Model Number: 41173E
• Device Catalogue Number: 41173E
• Device Lot Number: 23019232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/27/2023; 07/05/2023
• Supplement Dates FDA Received: 04/04/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2023
• 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