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

Catalog Number 361546

Device Problem Break (1069)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Medical device expiration date: unknown.Device manufacture date: unknown.Results: bd received 1 instrument returned from the customer facility for investigation.The returned unit was returned to the manufacturer for service, and it was observed that the tube cover was broken.The cover was replaced by the manufacturer and returned to the customer.Conclusion: based on the investigation, a root cause could not be determined within the scope of this evaluation.Bd was able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that the bd instrument sedi-40 tube cover was broken.No serious injury or medical intervention 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: 7100309
• MDR Text Key: 94987191
• Report Number: 2243072-2017-00367
• Device Sequence Number: 1
• Product Code: GHC
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 11/21/2017

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: 07/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 12/08/2017
• 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