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

Model Number 367283

Device Problems Leak/Splash (1354); Component Misassembled (4004)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: 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.Date of event: unknown.The date received by manufacturer has been used for this field.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 blood leakage or other sample leakage from the device and sleeve fell off.The following information was provided by the initial reporter.The customer stated: "the rubber back on needle detached, some blood spilled.Blood was flowing from needle and flowed down patient arm and onto floor.No expose to healthcare worker.".

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was blood leakage or other sample leakage from the device and sleeve fell off.The following information was provided by the initial reporter.The customer stated: "the rubber back on needle detached, some blood spilled.Blood was flowing from needle and flowed down patient arm and onto floor.No expose to healthcare worker.".

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-19.H.6.Investigation summary: bd received 46 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure modes for sleeve detached/leakage with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to sleeve detached/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 modes.Bd was not able to identify a root cause for the indicated failure modes.We highly advise customer return the used sample(s) and provide more detail about the event in case something similar happens in the future.In such case, we are willing to investigate further.

• 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: 15681886
• MDR Text Key: 307027416
• Report Number: 2243072-2022-01845
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 1L08B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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