MAUDE Adverse Event Report: BECTON DICKINSON BD ESR BI-LEVEL QC MATERIAL (4X8,5ML) ESR INSTRUMENT

Catalog Number 361555

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

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

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. Date of event: unknown. The date received by manufacturer has been used for this field. The reported lot# 195110 was not found for the catalog number. Device expiration date: n/a. Device manufacture date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that abnormal control occurred during use with a bd esr¿ bi-level qc material (4x8,5ml). The following information was provided by the initial reporter, "abnormal control of bottles was outside of the customer's defined 2s field. Original mail: i am writing to you regarding our bd sedi-40 device. We have recently received the new accu-sed plus controls (lot: 1945500-5). Now we have again the problem that the abnormal control (lot: 195110) is within the manufacturer's range but outside our 2s range. We have created several aliquots and mixed them well and always get a value of 42mm/hr (manufacturer's range 40-60mm/hr; target value of 50mm/hr). ".

• Brand Name: BD ESR BI-LEVEL QC MATERIAL (4X8,5ML)
• Type of Device: ESR INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9982671
• MDR Text Key: 189152643
• Report Number: 2243072-2020-00636
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 361555
• Device Lot Number: SEE. H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/21/2020 Patient Sequence Number: 1