MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 8.5 IN PRESSURE RATED MINIBORE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP5302-C

Device Problem Obstruction of Flow (2423)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported by customer that the 8.5 in pressure rated mini has multiple complaints from anesthesia that there is too much resistance when pushing drugs and they are unable to get a true "bolus flow" when needed for their patients during surgery.The following information was provided by the initial reporter: after all of these problems, our supply folks, ordered a similar product (mp5302-c) and the good thing: the luer locking mechanism is free flowing as it should be so those problems were resolved.However, the bad thing: it is definitely a "minibore" in size and now we are getting multiple complaints from anesthesia that there is too much resistance when pushing drugs and they are unable to get a true "bolus flow" when needed for their patients during surgery.This definitely could become an issue during an emergency situation as well.When you compare the 2 in size, it is very obvious that the minibore, which is the current one that is stocked and available for us, is much smaller in diameter.".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint that the set was unable to flush could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5302-c lot number 22109110 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.

Event Description

It was reported by customer that the 8.5 in pressure rated mini has multiple complaints from anesthesia that there is too much resistance when pushing drugs and they are unable to get a true "bolus flow" when needed for their patients during surgery.The following information was provided by the initial reporter: after all of these problems, our supply folks, ordered a similar product (mp5302-c) and the good thing: the luer locking mechanism is free flowing as it should be so those problems were resolved.However, the bad thing: it is definitely a "minibore" in size and now we are getting multiple complaints from anesthesia that there is too much resistance when pushing drugs and they are unable to get a true "bolus flow" when needed for their patients during surgery.This definitely could become an issue during an emergency situation as well.When you compare the 2 in size, it is very obvious that the minibore, which is the current one that is stocked and available for us, is much smaller in diameter.".

• Brand Name: 8.5 IN PRESSURE RATED MINIBORE 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: 16709461
• MDR Text Key: 313035360
• Report Number: 9616066-2023-00656
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403230131
• UDI-Public: (01)20885403230131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• 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: 05/01/2023

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: MP5302-C
• Device Lot Number: 22109110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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