MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® Z (NO ADDITIVE TUBES); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365963
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(6) with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for (b)(6) was/was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.
Event or Problem Description
It was reported that bd microtainer® z (no additive tubes) "micro - 365963 - tubes with water (la)".

• Brand Name: BD MICROTAINER® Z (NO ADDITIVE TUBES)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7488896
• Report Number: 2618282-2018-00556
• Device Sequence Number: 13781461
• Product Code: JKA
• UDI-Device Identifier: 50382903659635
• UDI-Public: 50382903659635
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 11/30/2017
• Device Catalogue Number: 365963
• Device Lot Number: 6148647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 05/04/2018
• 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