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

Model Number MZ1000-07

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem Not Applicable (3189)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that maxzero needleless connector was unable to flush.The following information was provided by the initial reporter: bag 7 contained one used 3ml bd syringe, lot number: 0091103 attached to one used mz1000-07, lot number: unknown --new material reported (maxzero).Follow up required for involvement in event.Customer sent one used 3ml bd syringe, lot number: 0091103, exp: 2023-02-28.Attached to one used mz1000-07, lot number: unknown.The maxzero was a newly reported item.The customer included a sticky note stating that, "unable to flush part when hanging ivf in rm 15.

Event Description

It was reported that maxzero needleless connector was unable to flush.The following information was provided by the initial reporter: bag 7 contained one used 3ml bd syringe, lot number: 0091103 attached to one used mz1000-07, lot number: unknown, new material reported (maxzero).Follow up required for involvement in event.Customer sent one used 3ml bd syringe, lot number: 0091103, exp: 2023-02-28.Attached to one used mz1000-07, lot number: unknown.The maxzero was a newly reported item.The customer included a sticky note stating that, "unable to flush part when hanging ivf in rm 15.

Manufacturer Narrative

Investigation summary one sample was returned for investigation.It was reported that this product does not flush.The sample was flushed.The sample was analyzed for defects.No defects were identified.The failure was unable to be replicated.A device history record review could not be performed on model mz1000-07 because a lot number was not provided by the customer.A root cause could not be determined because the failure was unable to be replicated.

• 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: 10646205
• MDR Text Key: 242381731
• Report Number: 9616066-2020-20033
• 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: 11/05/2020

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: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 12/05/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other