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

Catalog Number 368608

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

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 #: 7305593.Medical device expiration date: 2022-10-31.Device manufacture date: 2017-11-01.Medical device lot #: 7195565.Medical device expiration date: 2022-07-31.Device manufacture date: 2017-07-14.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle detached from the hub of several bd vacutainer® eclipse¿ blood collection needle(s).There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

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.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

Investigation summary: 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.6/25/2018 update: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for hub/collar separation with the incident lot was not observed.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.As a result, corrective actions have been established and implemented.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.6/25/2018 update: based on evaluation of the customer samples, the customer¿s indicated failure mode for hub/collar separation with the incident lot was not observed.Further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions have been implemented to mitigate further occurrences.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.(b)(6) 2018 update: a capa was conducted to document further investigation and root cause analysis relating to this issue.The investigation has identified the most likely root causes and corrective actions have been implemented.Capa (b)(4).Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.6/25/2018 update: 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 issue.The investigation has identified potential root cause(s) for this issue and corrective actions have been implemented.

• 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
• MDR Report Key: 7355122
• MDR Text Key: 103190678
• Report Number: 1024879-2018-00083
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686082
• UDI-Public: 50382903686082
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• 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
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other