MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MZ1000-07

Device Problem Leak/Splash (1354)

Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that maxzero needleless connector cracked while on patient.The following information was provided by the initial reporter: material no: mz1000-07 batch no: unknown.It was reported that bd maxzero needleless connector cracked while on patient with sedation running.Per customer email: bd maxzero needleless connector cracked while on patient with sedation running.Pt developed hypertension and mild hypoxia requiring beta-blocker dose and additional sedation bolus.Cap was changed and infusions restored.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint of maxzero needleless connector cracked could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mz1000-07 because a lot number was not provided by the customer.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 that maxzero needleless connector cracked while on patient.The following information was provided by the initial reporter: material no: mz1000-07.Batch no: unknown.It was reported that bd maxzero needleless connector cracked while on patient with sedation running.Per customer email: bd maxzero needleless connector cracked while on patient with sedation running.Pt developed hypertension and mild hypoxia requiring beta-blocker dose and additional sedation bolus.Cap was changed and infusions restored.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• 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 22244 ; MX 22244
• MDR Report Key: 10750773
• MDR Text Key: 213615855
• Report Number: 9616066-2020-20201
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention