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

Model Number 367281

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, (b)(4).Device evaluated by mfr 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 that during use with 10 bd vacutainer® safety-lok¿ blood collection set there was insufficient blood flow through the device.There was no report of patient impact.The following information was provided by the initial reporter: customer states blood begins to flow back into patient when tourniquet is removed.

Manufacturer Narrative

The following fields were updated with corrected information: d.4 medical device catalog #: 367283 d.4.Unique identifier (udi)(b)(4).

Event Description

It was reported that during use with 10 bd vacutainer® safety-lok¿ blood collection set there was insufficient blood flow through the device.There was no report of patient impact.The following information was provided by the initial reporter: customer states blood begins to flow back into patient when tourniquet is removed.

Event Description

It was reported that during use with 10 bd vacutainer® safety-lok¿ blood collection set there was insufficient blood flow through the device.There was no report of patient impact.The following information was provided by the initial reporter: customer states blood begins to flow back into patient when tourniquet is removed.

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 10-mar-2023.Bd received 3 samples and 1 video for investigation.The video was reviewed and the indicated failure mode for backflow was observed, however the tourniquet was removed too early in the blood collection process.According to the bd vacutainer evacuated blood collection system ifu (instructions for use), to prevent backflow the patient's arm should be placed in a downward position, the tube should be held with the stopper uppermost, and the tourniquet should be released only when blood starts to flow into the blood collection tube.These three steps were not followed in the submitted video.The customer samples were evaluated by visual examination and functional testing, each used to draw water into bd vacutainer tubes, and the indicated failure mode for backflow with the incident lot was not observed as all product specifications were met.Additionally, 50 retention samples from bd inventory, were evaluated by visual examination and no issues that could cause backflow were observed.An additional 8 retention samples were evaluated by functional testing, each used to draw bd vacutainer tubes with colored water, and no issues were found relating to backflow as all specifications were met.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 backflow.Bd determined that the root cause of the indicated failure mode was attributed to user error.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.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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16242990
• MDR Text Key: 308447118
• Report Number: 2243072-2023-00069
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672832
• UDI-Public: (01)50382903672832
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2014
• Device Model Number: 367281
• Device Catalogue Number: 367283
• Device Lot Number: 1H1921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2014
• 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