MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367955

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that bd vacutainer® sst¿ ii advance plus blood collection tubes had glass break during use causing exposure.The following information was provided by the initial reporter: "on (b)(6) 2020, a nurse used the tube lot (b)(4), when filling the tube with blood, while removing the holder, the tube got broken and she received blood on her.The doctor (b)(6) forwarded me this incident.The device could not be preserved (there was blood everywhere so it was thrown).So unfortunately i don't have a photo.It had broken just at the level of the cap.There were no significant consequences for the patient, however the technician concerned followed the procedure related to exposure to blood (consultation in the emergency room, serologies carried out, follow-up by the occupational doctor).".

Event Description

It was reported that bd vacutainer® sst¿ ii advance plus blood collection tubes had glass break during use causing exposure.The following information was provided by the initial reporter: "on (b)(6) 2020, a nurse used the tube lot 0161441 -367955, when filling the tube with blood, while removing the holder, the tube got broken and she received blood on her.The doctor (b)(6), forwarded me this incident.The device could not be preserved (there was blood everywhere so it was thrown).So unfortunately i don't have a photo.It had broken just at the level of the cap.There were no significant consequences for the patient, however the technician concerned followed the procedure related to exposure to blood (consultation in the emergency room, serologies carried out, follow-up by the occupational doctor).".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identifiy a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11127816
• MDR Text Key: 229365415
• Report Number: 9617032-2021-00012
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 0161441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention