MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

Catalog Number 368608

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7130743; medical device expiration date: 2022-04-30; device manufacture date: 2017-05-10; medical device lot #: 7125871; medical device expiration date: 2022-04-30 ; device manufacture date: 2017-05-05.Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.Bd has initiated further investigation relating to this issue through a capa and potential causes from the manufacturing process have been identified.As a result, corrective actions have been established and are in the process of being implemented.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Further investigation activities have been conducted relating to this product issue and possible root causes from the manufacturing process have been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Although no samples or photos were available for evaluation, bd has initiated further investigation through a capa.The investigation has identified possible root causes from the manufacturing process and corrective actions are in the process of being implemented.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this product issue.The investigation has identified potential root cause(s) from the manufacturing process for this issue and corrective actions are in the process of being implemented.

Event Description

It was reported that the safety shield of a bd vacutainer® eclipse¿ blood collection needle failed ("fell off") while trying to engage.There was no report of exposure, injury or medical intervention.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7276463
• MDR Text Key: 100521397
• Report Number: 1024879-2018-00036
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686082
• UDI-Public: 50382903686082
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K982541
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368608
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other