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

Catalog Number 367284

Device Problem Volume Accuracy Problem (1675)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced insufficient blood flow through the device.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the customer has used 6 of these and they all have the same problem, the draft does not occur and the blood does not flow while drawing blood, it gets stuck at the top of the small tube right after the needle.

Manufacturer Narrative

(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Lot#: batch 22c19t2 does not exist for material 367284.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 25 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to insufficient blood flow 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 insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® safety-lok¿ blood collection set, the device experienced insufficient blood flow through the device.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the customer has used 6 of these and they all have the same problem, the draft does not occur and the blood does not flow while drawing blood, it gets stuck at the top of the small tube right after the needle.

Manufacturer Narrative

D tab update: returned to manufacturer on 11/07/2022.H tab updated: device return to manuf, device return eval by manuf? both updated to "yes".H6: investigation summary "material # 367284 lot/batch # 22c19t2.Bd received 44 samples for investigation.The samples were evaluated by visual examination and 5 by functional testing, each used to draw colored water into blood collection tubes, and the indicated failure mode for insufficient flow with the incident lot was not observed.Additionally, 25 retention samples from bd inventory were evaluated by visual examination and the same functional testing and no issues were observed relating to insufficient flow 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 insufficient blood flow.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, the device experienced insufficient blood flow through the device.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: the customer has used 6 of these and they all have the same problem, the draft does not occur and the blood does not flow while drawing blood, it gets stuck at the top of the small tube right after the needle.

• 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: 15848437
• MDR Text Key: 307673553
• Report Number: 2243072-2022-02034
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367284
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1