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

Catalog Number 361546

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device lot # unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.Results: a sample was returned for evaluation, the instrument was tested and was found to be incorrectly calibrated ¿ this was corrected and a new fan installed as the existing one was noisy.Conclusion: root cause is indeterminate.

Event Description

It was reported that bd instrument sedi-40 had llo messages and inadequate filling upon use.No medical intervention or injury reported.

• Brand Name: BD INSTRUMENT SEDI-40
• Type of Device: SEDIMENTION 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 ; 8015652845
• MDR Report Key: 7081305
• MDR Text Key: 94409365
• Report Number: 2243072-2017-00296
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Type of Report: Initial
• Report Date: 11/14/2017

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: 04/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 12/04/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other