MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD¿ TUBE MEDIA TUBE LIHEP PLH; BLOOD COLLECTION TUBE

Catalog Number	368494
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for color variation with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation and upon completion, the issue relating to color variation was not observed.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for color variation with the incident lot was observed.Additionally, evaluation of the retain samples was conducted and color variation was not observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.As a result, bd is reviewing specific areas in the manufacturing process where the cause of this issue may have originated.
Event or Problem Description
It was reported that a bd¿ tube media tube lihep plh had a cap with a lighter green color.The color was too light, similar to the grey cap."this makes the inpeco track the lihep tube no longer recognizes, places it in an error rack and analysis is postponed.This reduces the tat and the time to result, which results in delays in diagnosing patients.".

• Brand Name: BD¿ TUBE MEDIA TUBE LIHEP PLH
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 8152057
• Report Number: 9617032-2018-03200
• Device Sequence Number: 2325159
• Product Code: JKA
• UDI-Device Identifier: 00382903684946
• UDI-Public: 382903684946
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 368494
• Device Lot Number: 8177989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other