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

Catalog Number 421417

Device Problem Defective Device (2588)

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

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd ds headquarters in (b)(4) has been listed as oem - (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 7th device with this catalog number manufactured in feb.1983.

Event Description

It was reported that a bd adams¿ compact ii centrifuge was spinning with the lid open.No injuries were reported.

Event Description

It was reported that a bd adams¿ compact ii centrifuge was spinning with the lid open.No injuries were reported.

Manufacturer Narrative

H.6.Investigation summary customer reported that the autocrit instrument 146007a would spin while the lid was still open.No one was harmed from the exposed spinning components of the centrifuge.The customer was instructed as to what part to order from the manufacturer.The customer did not respond.This is an unconfirmed failure of the system.The root cause is undetermined at this time.Assignable causes include: defective pcb assembly that controls latch release or a defective latch dhr review is not required as the complaint is not an alleged failure at install or early life failure.Material was not returned for investigation.The immediate correction was to give the customer the spare part number to order from the manufacturer.Corrective action is not required as the failure mode is within allowable limits.Bd quality will continue to closely monitor trends associated with the failure of safety.

• 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: 9369913
• MDR Text Key: 191155085
• Report Number: 1119779-2019-00118
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 421417
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other