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 Material Rupture (1546)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

It was reported that the bd maxplus needleless connector experienced defective tubing.The following information was provided by the initial reporter: the product does not handle pressure injections particularly in ct where injection contrast media occurs at 5ml/sec.The iv is either exploding or causes an error with the injector.This is leading to having to re-radiate the patient to get a contrasted exam completed.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.

Manufacturer Narrative

H6: investigation summary: a photo received and verified the customer's complaint of leakage.The set is clearly separated.Without a physical sample for investigation, the root cause remains unknown.If this type of failure occurs again, please provide the affected sample for investigation into failure cause.A device history record review could not be performed because a lot number was not provided by the customer.

Event Description

It was reported that the bd maxplus needleless connector experienced defective tubing.The following information was provided by the initial reporter: the product does not handle pressure injections particularly in ct where injection contrast media occurs at 5ml/sec.The iv is either exploding or causes an error with the injector.This is leading to having to re-radiate the patient to get a contrasted exam completed.

• 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: 14131376
• MDR Text Key: 289467224
• Report Number: 9616066-2022-00392
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• 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: 07/27/2022
• 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