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

Catalog Number 368835

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for separation of the holder from the needle with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the customer's indicated failure was not observed as all retention 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.Based on evaluation of the customer photos and samples, the customer¿s indicated failure mode for separation of the holder from the needle with the incident lot was observed and the most likely root cause was determined to be related to a manufacturing issue.

Event Description

It was reported that after injection, when healthcare provider inserted the bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder, the needle detached from the holder.There was no report of injury or medical intervention.

• Brand Name: BD VACUTAINER® ECLIPSESIGNAL¿ BLOOD COLLECTION NEEDLE W/ 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: 7168431
• MDR Text Key: 96624019
• Report Number: 9617032-2017-00671
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 368835
• Device Lot Number: 7151632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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