MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SEDI-40; SEDIMENTION INSTRUMENT

Catalog Number 383715

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 with the use of the bd sedi-40 there was an issue with potential injury.It was stated ¿two patients found that the heparin cap was partially detached from the top of the silicone.Heparin cap came off the top of the silicone".There was no report of injury or further medical intervention.

Manufacturer Narrative

A sample was received for the purpose of our investigation.The investigators were unable to observe the reported failure mode in the sample provided, because the affected component was not returned with the rest of the device.The batch record also was reviewed, no related abnormalities were found.Without the affected component being available for investigation bd was unable to determine the root cause of this complaint.

• Brand Name: BD SEDI-40
• Type of Device: SEDIMENTION INSTRUMENT
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7527777
• MDR Text Key: 109009529
• Report Number: 8041187-2018-00160
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 383715
• Device Lot Number: 6085111
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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