MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367300

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/08/2023

Event Type  Injury  

Event Description

It was reported that while using bd vacutainer® multiple sample luer adapter, the luer adapter and stopcock did not come off, resulting in a needle stick of a health care professional.No treatment information available.The customer reported that blood was collected by connecting the single-use holder (364815), luer adapter (367300 ), stopcock, and winged needle in that order, but when it was removed, the luer adapter and stopcock did not come off, resulting in a needle stick.

Manufacturer Narrative

D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.E.1.Initial reporter facility name: (b)(6) hospital.H.4.Device manufacture date: unknown h.6.Investigation summary: material #: 367300, lot/batch #: unknown, 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.

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17859303
• MDR Text Key: 324765846
• Report Number: 1024879-2023-00669
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• 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
• Patient Outcome(s): Other