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

Catalog Number 368835

Device Problems Detachment Of Device Component (1104); Fail-Safe Design Failure (1222); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).Summary - bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for separation of the needle and holder with the incident lot was observed.However, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion - based on evaluation of the customer photos, the customer¿s indicated failure mode for separation of the needle and holder with the incident lot was observed.Root cause - based on the investigation, a root cause could not be determined.

Event Description

It was reported during use of the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder.It was stated ¿that the needle moved further into the vein by itself, almost with a spring like action.The holder and safety guard of the device became completely detached from the needle.¿ the nurse then proceeded to push the vacutainer onto to the back end of the needle, holding the needle with a cotton ball, even though the holder was not there, and successfully collected the sample.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: 2/20/2018 update: retention samples were selected from bd inventory for testing and upon completion, the customer's indicated failure mode for separation of the needle and holder was not observed as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.These additions did not change the outcome of the initial investigation.

Manufacturer Narrative

Medical device expiration date: changed from "unknown" to "09/30/2020".Medical device lot #: changed from "unknown" to lot number "7262855".Device manufacture date: changed from "unknown" to "09/19/2017.".

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ INTEGRATED HOLDER
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7187836
• MDR Text Key: 97664675
• Report Number: 9617032-2017-00679
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 368835
• Device Lot Number: 7262855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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
• Patient Outcome(s): Other