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

Catalog Number 367282

Device Problem Leak/Splash (1354)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® safety-lok¿ blood collection set, sleeve leakage is seen in four (4) devices.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.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Material #: 367282.Lot/batch #: 23j26t1.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and another 5 retention samples by functional draw testing and no issues were observed relating to sleeve leakage as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode sleeve leakage.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that while using bd vacutainer® safety-lok¿ blood collection set, sleeve leakage is seen in four (4) devices.No patient impact reported.

• 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: 19019412
• MDR Text Key: 339131458
• Report Number: 2243072-2024-00487
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903672820
• UDI-Public: (01)00382903672820
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367282
• Device Lot Number: 23J26T1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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