MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

Catalog Number 368610

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The reported lot numbers [8011769, 7325683] were not found for the reported catalog number [368610].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that foreign matter was found attached to the needle shaft of the bd eclipse¿ blood collection needle with luer adapter after removing the seal.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that foreign matter was found attached to the needle shaft of the bd eclipse blood collection needle with luer adapter after removing the seal.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Bd received samples and photos from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for foreign matter on the needle with the incident lot was observed.The photos were evaluated and the customer's indicated failure mode for foreign matter on the needle was observed.A review of the device history record was completed for the incident lots 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, the customer¿s indicated failure mode for foreign matter on the needle was observed.Based on evaluation of the customer samples, the customer¿s indicated failure mode for foreign matter on the needle with the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.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

Correction: the initial mdr reported that the lot numbers (8011769 and 7325683) that were reported by the customer were not valid for the reported catalog number.This information has been corrected.Medical device lot #: 8011769.Medical device expiration date: 2022-12-31.Device manufacture date: 2018-03-22.Medical device lot #: 7325683.Medical device expiration date: 2022-11-30.Device manufacture date: 2017-11-21.

Event Description

It was reported that foreign matter was found attached to the needle shaft of the bd eclipse¿ blood collection needle with luer adapter after removing the seal.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7889191
• MDR Text Key: 121447187
• Report Number: 1024879-2018-01205
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/02/2018

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: Health Professional
• Device Catalogue Number: 368610
• Device Lot Number: SEE SECTION H.10.
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 08/28/2018
• Supplement Dates FDA Received: 11/05/2018; 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other