MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT

Catalog Number 364946

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.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.

Event Description

It was reported that 16mm x 100mm x 8ml bd vacutainer® plus plastic collection kit was yielding erroneous results.No report of injury or medical intervention.No report of blood exposure to mucous membrane.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.

Event Description

It was reported that 16mm x 100mm x 8ml bd vacutainer plus plastic collection kit was yielding erroneous results.No report of injury or medical intervention.No report of blood exposure to mucous membrane.

• Brand Name: 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT
• Type of Device: COLLECTION KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7700531
• MDR Text Key: 114431100
• Report Number: 1917413-2018-03087
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 00382903649464
• UDI-Public: 00382903649464
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364946
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other