MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES; SPECIMEN TRANSPORT & STORAGE CONTAINER

Model Number	362725
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	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® est z (no additive) plus blood collection tubes cap was the wrong color.This was discovered before use.The following information was provided by the initial reporter: wrong cap colour to product code.
Event or Problem Description
It was reported that bd vacutainer® est z (no additive) plus blood collection tubes cap was the wrong color.This was discovered before use.The following information was provided by the initial reporter: wrong cap color to product code.
Additional Manufacturer Narrative
H.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 incorrect cap color with the incident lot was 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.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.H3 other text : see section h.10.

• Brand Name: BD VACUTAINER® EST Z (NO ADDITIVE) PLUS BLOOD COLLECTION TUBES
• Common Device Name: SPECIMEN TRANSPORT & STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9480925
• Report Number: 9617032-2019-01468
• Device Sequence Number: 11556220
• Product Code: FMH
• UDI-Device Identifier: 50382903627252
• UDI-Public: 50382903627252
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 01/20/2020

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: 02/28/2021
• Device Model Number: 362725
• Device Catalogue Number: 362725
• Device Lot Number: 9235321
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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