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

Catalog Number 367296

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that prior to using bd vacutainer® safety-lok¿ blood collection set, there is no expiration date on the box, product insert, or package.No patient impact reported.

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.D4.The customer provided lot number 5b2661, however, this does not coincide with the material number affected.Therefore, the lot number has been listed as unknown.E1: initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.H.6.Investigation summary: material #: 367296 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® 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: 19043045
• MDR Text Key: 340118359
• Report Number: 2243072-2024-00501
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903672967
• UDI-Public: (01)00382903672967
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367296
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/04/2024
• 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