MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD SEDI-40; ESR INSTRUMENT

Catalog Number 361546

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Expiration date unknown, lot number unknown, unique identifier (udi) # is unknown, date device returned to manufacturer is unknown, the date supplied is the date of investigation.(b)(6).Manufacture date unknown.Bd received the instrument from the customer facility for investigation.The instrument was evaluated and the customer's indicated failure mode for 91818 with the incident lot was observed.

Event Description

It was reported that while using the bd sedi-40, the instrument was not working properly.The reporter stated, "after mixing samples it prints wrong information without results nor ids.

• Brand Name: BD SEDI-40
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7477812
• MDR Text Key: 107355550
• Report Number: 9617032-2018-00888
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2018

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 Catalogue Number: 361546
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other