MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365992
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.No lot # provided.Device manufacture date: unknown.Results: a sample or photo is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported the bd microtainer® tubes with fe (sodium fluoride/disodium edta) were clotting, no report of medical interventions or serious injury.

• Brand Name: BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7519560
• Report Number: 2618282-2018-00373
• Device Sequence Number: 16647035
• Product Code: JKA
• UDI-Device Identifier: 50382903659925
• UDI-Public: 50382903659925
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K002456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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 Catalogue Number: 365992
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2013
• Initial Report FDA Received Date: 05/16/2018
• 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