MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/27/2022

Event Type  Injury  

Event Description

It was reported that bd q-syte luer access split septum leaked necessitating medical intervention.The following information was provided by the initial reporter: "around this time, the nurse rechecked the iv line and discovered droplets on the connection between the nad q-syte and the syringe as well as on the syringe pump.The iv line was replaced immediately; with the hr of the 40 level, atropine 1a was intravenously administered, which led to hr elevation, followed by administration of neocinedin, which led to bp elevation to the 70mmhg level.Then, nad was restarted.The bp was elevated to 120 mmhg within 5 minutes.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.Medical device expiration date: unknown.Device manufacture date: unknown.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: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

Event Description

It was reported that bd q-syte luer access split septum leaked necessitating medical intervention.The following information was provided by the initial reporter: "around this time, the nurse rechecked the iv line and discovered droplets on the connection between the nad q-syte and the syringe as well as on the syringe pump.The iv line was replaced immediately; with the hr of the 40 level, atropine 1a was intravenously administered, which led to hr elevation, followed by administration of neocinedin, which led to bp elevation to the 70mmhg level.Then, nad was restarted.The bp was elevated to 120 mmhg within 5 minutes.".

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT SEPTUM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13514060
• MDR Text Key: 286672247
• Report Number: 9610847-2022-00059
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention