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

Catalog Number 367292

Device Problem Leak/Splash (1354)

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

Event Date 03/31/2024

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® safety-lok¿ blood collection set, there was sleeve leakage seen in one (1) device.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.6.Investigation summary: material #: 367292.Lot/batch #: 2j21a1.Bd received 5 samples for investigation.The samples were evaluated by visual examination and functional draw testing and the indicated failure mode for sleeve leakage with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and another 8 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.It is important that a tube holder is used with the safety-lok wingset as it prevents the blood collection tube from being pushed too far onto the non-patient cannula.Without the holder, if the blood collection tube is pushed too far it can cause the rubber sleeve to be pushed out of position and be unable to fully recover the non-patient cannula.H3 other text : see h.10.

• 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: 19192667
• MDR Text Key: 341817967
• Report Number: 2243072-2024-00567
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903672929
• UDI-Public: (01)00382903672929
• Combination Product (y/n): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

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: 367292
• Device Lot Number: 2J21A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2022
• 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