MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD MAXPLUS EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

Patient Problem Hematoma (1884)

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that during use with an unspecified bd maxplus extension set it occluded and blood clotting occurred.Therapy was delayed, however, there was no additional impact.The following information was provided by the initial reporter: clinician experienced: blood clots on the connector.- interruption of patient therapy (not resulting in patient injury).

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown, device manufacture date: unknown.Investigation summary: no samples were received for investigation of complaint reported via post market survey; however the customer has indicated that occlusion was detected during use of the extension set as a result of blood clotting within the infusion line.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.

• Brand Name: UNSPECIFIED BD MAXPLUS EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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 ; 8448235433
• MDR Report Key: 16500836
• MDR Text Key: 310882728
• Report Number: 2243072-2023-00318
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• 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