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

Model Number 367988

Device Problem Difficult to Insert (1316)

Patient Problem Pain (1994)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported that during draw with bd vacutainer® sst¿ blood collection tubes the tube pushed off non patient end of needle, causing patient discomfort.The following information was provided by the initial reporter: customer reports that when drawing blood, the runner part of tubes get stuck inside of the plastic vacuums, causing patient discomfort.

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.

Manufacturer Narrative

H.6.Investigation summary: 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.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that during draw with bd vacutainer® sst¿ blood collection tubes the tube pushed off non patient end of needle, causing patient discomfort.The following information was provided by the initial reporter: customer reports that when drawing blood, the runner part of tubes get stuck inside of the plastic vacuums, causing patient discomfort.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16740476
• MDR Text Key: 313324370
• Report Number: 1024879-2023-00226
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: (01)50382903679886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1