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

Catalog Number	CM42500E-07
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd gravity set valve malfunctioned.The following information was received by the initial reporter with the verbatim: a provider attached a phenylephrine syringe to the three way stop cock of the bd gravity iv set.Administered 50mcg phenylephrine.Then attached a 10cc syringe to the distal side port and withdrew a flush and subsequently pushed it.Not long after that, the patient experienced significant and concerning hypertension.With investigation, the phenylephrine syringe was found to be empty attached to the three way stop cock.In the end, the back check valve failed, and the phenylephrine syringe was drawn up into the flush syringe and roughly 1000mcg was pushed as a bolus unknowingly.Of note, if the roller ball was wide open, the flush syringe did not empty the stop cock syringe.It followed the path of least resistance and pulled from the iv fluid bag.If we closed the roller ball at all, the stop cock syringe was aspirated into the flush syringe.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
The customer reported that there was backflow.One video was taken by the customer that verifies the complaint.A notification was sent to the supplier but due to no sample or lot being received no further investigation can be conducted.The root cause could not be determined because the sample was not returned.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD GRAVITY SET
• Common Device Name: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18531925
• Report Number: 9616066-2024-00021
• Device Sequence Number: 6750516
• Product Code: FPA
• UDI-Device Identifier: 10885403473746
• UDI-Public: (01)10885403473746
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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
• Operator of Device: Other
• Device Catalogue Number: CM42500E-07
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown