MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 362753

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/06/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that during centrifugation with bd vacutainer® cpt¿ cell preparation tube with sodium heparin the tube broke and cut hcp.The following information was provided by the initial reporter, translated from (b)(6) to english: a tube was broken during centrifugation due to a damaged stopper and an hcp was injured.The injury, however, was mild and no serious health hazard was reported.

Manufacturer Narrative

Investigation: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.Complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that during centrifugation with bd vacutainer® cpt¿ cell preparation tube with sodium heparin the tube broke and cut hcp.The following information was provided by the initial reporter, translated from japanese to english: a tube was broken during centrifugation due to a damaged stopper and an hcp was injured.The injury, however, was mild and no serious health hazard was reported.

• Brand Name: BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11097592
• MDR Text Key: 224527865
• Report Number: 1917413-2020-01272
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903627535
• UDI-Public: 50382903627535
• Combination Product (y/n): N
• PMA/PMN Number: K891407
• 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: 01/15/2021

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 Model Number: 362753
• Device Catalogue Number: 362753
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other