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

Model Number	365967
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2020
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 a tube was discovered to be cracked with a bd microtainer® sst¿.The following information was provided by the initial reporter, translated from japanese to english: a crack on the tube was found before use and the tube was thus not used.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to cracked tube as all samples met specifications.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 a tube was discovered to be cracked with a bd microtainer® sst¿.The following information was provided by the initial reporter, translated from japanese to english: a crack on the tube was found before use and the tube was thus not used.

• 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: 10240563
• Report Number: 2618282-2020-00059
• Device Sequence Number: 2603104
• 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): 08/11/2020

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: 02/28/2021
• Device Model Number: 365967
• Device Catalogue Number: 365967
• Device Lot Number: 9337915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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