MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD ADAMS¿ COMPACT II CENTRIFUGE; GENERAL PURPOSE LABORATORY EQUIPMENT

Catalog Number 420225

Device Problem Mechanics Altered (2984)

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

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd ds headquarters in sparks, md has been listed =as oem - the (b)(4) is an oem manufacturing site.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Based on the provided serial number, this device was the 214th device with this catalog number manufactured in jan.1993.

Event Description

It was reported that a bd adams¿ compact ii centrifuge was spinning with the lid open.

Event Description

It was reported that a bd adams¿ compact ii centrifuge was spinning with the lid open.

Manufacturer Narrative

Investigation summary: the complaint of a defective lid on a compact ii centrifuge is confirmed (s/n: (b)(4), manufactured in 1993).Customer reported that the unit¿s lid would open before spinning cycle was complete.Customer received a replacement unit.Return of the unit was requested (ups tracking no.(b)(4)) but not received by quality for further investigation.No further action is required at this time.Bd instrument plant will continue to monitor for trends associated with this defect.Investigation conclusion: the service history was reviewed for this instrument and no issues were identified.Hazard analysis: this issue is listed as an s4, ¿severe injury to operator¿s hand, exposure to biohazards¿.Root cause description: no returns received by quality, so the cause was not determined.Rationale: since the root cause could not be determined, no trends with this unit could be identified.

• Brand Name: BD ADAMS¿ COMPACT II CENTRIFUGE
• Type of Device: GENERAL PURPOSE LABORATORY EQUIPMENT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 7879111
• MDR Text Key: 120527696
• Report Number: 1119779-2018-00012
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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: 420225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other