MAUDE Adverse Event Report: BECTON DICKINSON BD SEDI-40; ESR INSTRUMENT

Catalog Number 361546

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

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.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that the bd sedi-40 experienced a hardware/software malfunction for an esr instrument during use.The following information was provided by the initial reporter: after mixing the tubes are starting to shake and stir.

Event Description

It was reported that the bd sedi-40 experienced a hardware/software malfunction for an esr instrument during use.The following information was provided by the initial reporter: after mixing the tubes are starting to shake and stir.

Manufacturer Narrative

H.6.Investigation summary bd had performed a technical evaluation of the customer's sedi-40 instrument.It was determined that there was a loose timing belt sprocket which led to the reported shaking.Upon completion of the instrument repair, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.H3 other text : see section h.10.

• Brand Name: BD SEDI-40
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9476154
• MDR Text Key: 176972945
• Report Number: 2243072-2019-02830
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

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
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other