MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER SST; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	365967
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that prior to use with a bd microtainer® sst¿ the shield was discolored.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer reports that the shield was partially discolored (the shield partially turned red).
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for mixed colors with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that prior to use with a bd microtainer® sst¿ the shield was discolored.The following information was provided by the initial reporter, translated from japanese to english: the customer reports that the shield was partially discolored (the shield partially turned red).

• Brand Name: BD MICROTAINER SST
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10703479
• Report Number: 2618282-2020-00082
• Device Sequence Number: 11574781
• Product Code: JKA
• UDI-Device Identifier: 50382903659673
• UDI-Public: 50382903659673
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: 365967
• Device Catalogue Number: 365967
• Device Lot Number: 0086468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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