MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 367364

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that pseudo occurred with a bd vacutainer® ultratouch¿ push button blood collection set.The following information was provided by the initial reporter, "pseudoaneurysm occurred on february 12 for patients who performed blood collection on january 22 one hour after blood collection, the blood collection trace turned blue, but no pain was felt during blood collection.No medication history.The causal relationship with the device is unknown.".

Event Description

It was reported that pseudo occurred with a bd vacutainer® ultratouch¿ push button blood collection set.The following information was provided by the initial reporter, "pseudoaneurysm occurred on february 12 for patients who performed blood collection on january 22.One hour after blood collection, the blood collection trace turned blue, but no pain was felt during blood collection.No medication history.The causal relationship with the device is unknown.".

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer facility 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.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9788984
• MDR Text Key: 184154847
• Report Number: 1024879-2020-00164
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• PMA/PMN Number: K153309
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 367364
• Device Catalogue Number: 367364
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other