MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE

Catalog Number 301746

Device Problem Packaging Problem (3007)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

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® flashback blood collection needle, the device experienced.The following information was provided by the initial reporter.The customer stated: one straight needle had some needles of this lot with no paper label.

Manufacturer Narrative

B.5.Event description : it was reported when using the bd vacutainer® flashback blood collection needle, the device experienced missing label information.The following information was provided by the initial reporter.The customer stated: one straight needle had some needles of this lot with no paper label.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure modes for hooked needle point and missing unit label were observed.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 has been confirmed for the indicated failure modes hooked needle point and missing unit label.Bd determined that the root cause of the hooked needle point was attributed to the manufacturing process and corrective actions have been made to help prevent hooked needle points.This complaint lot has been manufactured before completion of these corrective actions.Bd was not able to identify a root cause for the missing unit label.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® flashback blood collection needle, the device experienced missing label information.The following information was provided by the initial reporter.The customer stated: one straight needle had some needles of this lot with no paper label.

• Brand Name: BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14633751
• MDR Text Key: 300803589
• Report Number: 8041187-2022-00290
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 301746
• Device Lot Number: 1265132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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