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

Catalog Number 36154608

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Medical device model #: unknown.Device manufacture date: unknown.Date device returned to manufacturer is unknown.The date of investigation was used.Bd received the sample from the customer facility for investigation.The samples was evaluated and the customer's indicated failure mode for broken hardware was observed.However, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

Event Description

It was reported that the bd sedi-40 was broken and would not hold the tubes tightly enough.

• Brand Name: BD SEDI-40
• 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 ; 8015652845
• MDR Report Key: 7493026
• MDR Text Key: 107722001
• Report Number: 2243072-2018-00726
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/27/2018

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: 36154608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 05/07/2018
• 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