MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 368650

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 12/05/2019

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 that a shield malfunction occurred during use with a bd vacutainer® eclipse¿ blood collection needle with pre-attached holder.The following information was provided by the initial reporter, "the shield of the eclipse preattached breaks away from the needle, it seems as the shield is not firmly attached to the needle and while the health care worker activates the safety closure the shield breaks away." 2 occurrences reported.

Event Description

It was reported that a shield malfunction occurred during use with a bd vacutainer® eclipse¿ blood collection needle with pre-attached holder.The following information was provided by the initial reporter, "the shield of the eclipse preattached breaks away from the needle, it seems as the shield is not firmly attached to the needle and while the health care worker activates the safety closure the shield breaks away." (b)(4) occurrences reported.

Manufacturer Narrative

H.6.Investigation: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for safety shield falling off with the incident lot was not observed as all product specifications were met.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9522091
• MDR Text Key: 181378396
• Report Number: 1024879-2019-02175
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 50382903686501
• UDI-Public: 50382903686501
• Combination Product (y/n): N
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 368650
• Device Catalogue Number: 368650
• Device Lot Number: 9182294
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other