MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PLATE MCCDA CLEAR - HT

Catalog Number 252950

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the defect was not confirmed because there is no picture and returned sample.A customer report is not required, and it is known defect and the trend has not shown a remarkable rise, so we decided that further investigations is not necessary.We will continue to monitor the trend this issue.

Event Description

It was reported that prior to use with bd plate mccda clear - ht the plate was discovered to be contaminated.

• Brand Name: BD PLATE MCCDA CLEAR - HT
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11293370
• MDR Text Key: 232046809
• Report Number: 1119779-2021-00261
• Device Sequence Number: 1
• Product Code: JTN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: 252950
• Device Lot Number: 0282462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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