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

Model Number 367283

Device Problem Break (1069)

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

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was a needle and holder separate/spin out issue and the cannula separated or pulled out.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the device fell apart.When connecting the needle for blood collection it pulls out.When the doctor tried to use the butterfly to draw a patients' sample, it came apart.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and another 8 by luer adapter spin out testing, connecting each sample to a bd single use holder and inserting bd vacutainer tubes, and no issues were observed relating to luer / needle separation 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 luer / needle separation.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.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was a needle and holder separate/spin out issue and the cannula separated or pulled out.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the device fell apart.When connecting the needle for blood collection it pulls out.When the doctor tried to use the butterfly to draw a patients' sample, it came apart.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16142573
• MDR Text Key: 308589371
• Report Number: 2243072-2023-00007
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672832
• UDI-Public: 50382903672832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• 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,Followup
• Report Date: 01/24/2023

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 Model Number: 367283
• Device Catalogue Number: 367283
• Device Lot Number: 2E02B1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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