MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367285

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/24/2023

Event Type  Injury  

Event Description

It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hic, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 2 of 4.

Manufacturer Narrative

The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.G.5: pma / 510(k)#k980414 , k991088.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following field was updated with corrected information: b.3.Date of event: (b)(6) 2023.

Event Description

It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hiv, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 2 of 4.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18970088
• MDR Text Key: 338504703
• Report Number: 2243072-2024-00441
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672856
• UDI-Public: (01)50382903672856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367285
• Device Lot Number: 23D2211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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): Required Intervention