MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD MAX INSTRUMENT

Catalog Number 44191609

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd ds headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Serial creation date: unknown.

Event Description

It was reported that bd max¿ instrument door closed too quickly and bruised the customers hand.The following information was provided by the initial reporter: the customer announced that the door closes too quickly.No more resistance when closing, gravity lets the door close quickly.Probably the suspension / hydraulics are defective.The customer bruised his hand.The swelling has already subsided.

Manufacturer Narrative

H.6.Investigation: the complaint of "door won't stay open" was reported against the bd max refurbished instrument catalog number 44191609, serial number (b)(6).The customer reported that the instrument door closes too quickly.The door would close without any resistance and would fall shut.The customer received injury on hand from the issue.Field service was dispatched.Field service determined that the gas spring cylinder came loose, disconnecting the gas cylinder from the door.Field service reconnected the gas cylinder and applied loctite.No parts were replaced for this case.Root cause is determined to be that the gas cylinder came unscrewed from the socket.The complaint is confirmed as an instrument issue.The investigation consisted of a review of the instrument installation, and service history, and related complaint data.No new risks, trends, or hazards were identified.Bd will continually monitor for trend.

Event Description

It was reported that bd max¿ instrument door closed too quickly and bruised the customers hand.The following information was provided by the initial reporter: the customer announced that the door closes too quickly.No more resistance when closing, gravity lets the door close quickly.Probably the suspension / hydraulics are defective.The customer bruised his hand.The swelling has already subsided.

• Brand Name: BD MAX INSTRUMENT
• Type of Device: BD MAX INSTRUMENT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 12469387
• MDR Text Key: 275285919
• Report Number: 1119779-2021-01511
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 44191609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1