MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368836

Device Problem Premature Separation (4045)

Patient Problem Discomfort (2330)

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder malfunctions when taking samples, leaving the needle exposed without the holder when drawing blood.Patient 1 of 3.The following information was provided by the initial reporter.The customer stated: from the customer: after we stick a patient, the sleeve itself has come off the needle and the needle is left in the patient's arm with the needle perforating the test tubes exposed without the sleeve protecting it.This has happened on three separate occasions and for three different test takers.When examining two of the sleeves, it looks like the plastic sleeves have cracked on the side where they attach to the needles.We have now taken all needles with the same lot no.Out of order.

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

D10: device available for eval: yes.D10: returned to manufacturer on: 17-oct-2023.H6.Investigation summary: bd received 560 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for holder breaks off with the incident lot was not observed.Additionally, 10 of the returned samples along with 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes, and no issues were observed relating to holder breaks off 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 holder breaks off.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® eclipse¿ signal¿ blood collection needle with integrated holder malfunctions when taking samples, leaving the needle exposed without the holder when drawing blood.Patient 1 of 3.The following information was provided by the initial reporter.The customer stated: from the customer: after we stick a patient, the sleeve itself has come off the needle and the needle is left in the patient's arm with the needle perforating the test tubes exposed without the sleeve protecting it.This has happened on three separate occasions and for three different test takers.When examining two of the sleeves, it looks like the plastic sleeves have cracked on the side where they attach to the needles.We have now taken all needles with the same lot no.Out of order.

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17757121
• MDR Text Key: 323529032
• Report Number: 9617032-2023-01209
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368836
• Device Lot Number: 3142290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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