MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD GRAVITY BURETTE SET 60 DP 3 SMARTSITE; INTRAVASCULAR ADMINISTRATION SET

Model Number 10012564

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported while using bd gravity burette set 60 dp 3 smartsite the tubing ruptured.This occurred 7 times.There was no report of patient impact.The following information was provided by the initial reporter: injuries or adverse event: no.Item: 10012564; quantity affected: 7 each; serial/lot number: (b)(6); po : (b)(4).Are any samples available for return? yes.Reported issue: exploding.Customer disposition request: credit.

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a complaint of tubing exploding was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.A device history record review for model 10012564 lot number 22039290 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 no sample being received, an investigation could not be performed, and a root cause could not be determined.H3 other text : see h10.

Event Description

It was reported while using bd gravity burette set 60 dp 3 smartsite the tubing ruptured.This occurred 7 times.There was no report of patient impact.The following information was provided by the initial reporter: injuries or adverse event: no item: 10012564 quantity affected: 7 each serial/lot number: (b)(6) po : 4516069865 are any samples available for return? yes.Reported issue: exploding.Customer disposition request: credit.

• Brand Name: BD GRAVITY BURETTE SET 60 DP 3 SMARTSITE
• 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: 17259588
• MDR Text Key: 319281661
• Report Number: 9616066-2023-01352
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951922
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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: 10012564
• Device Catalogue Number: 10012564
• Device Lot Number: 22039290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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