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

Catalog Number MP1000-C

Device Problem Backflow (1064)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported bd maxplus¿ needleless connector had flow issues.The following information was provided by the initial reporter: "connector is pushing the tracer back out and causing lots of contamination.".

Event Description

It was reported bd maxplus¿ needleless connector had flow issues.The following information was provided by the initial reporter: "connector is pushing the tracer back out and causing lots of contamination.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that mp1000-c connector is pushing the tracer back out and causing lots of contamination.The customer complaint 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 mp1000-c because a lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD MAXPLUS¿ 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
• 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 ; 8015296192
• MDR Report Key: 13869214
• MDR Text Key: 287808443
• Report Number: 9616066-2022-00299
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403223225
• UDI-Public: 20885403223225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072542
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP1000-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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