MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366882
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2016
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 with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode was not observed as all samples met specifications.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 vacutainer® sst¿ ii advance plus blood collection tubes had label flaws.No serious injury or medical intervention reported.
Additional Manufacturer Narrative
This complaint is not mdr reportable.Any flaw (crease or smear) would not have any impact on the tube use.The user would still be able to identify the tube and the analyte that it was designed to be utilized for.The tube would still function as it was intended.This mdr was created and submitted in error using incorrect reporting rationale.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7568957
• Report Number: 9617032-2018-01035
• Device Sequence Number: 19286074
• Product Code: JKA
• UDI-Device Identifier: 50382903668828
• UDI-Public: 50382903668828
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK050036
• 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,Followup
• Report Date (Section B): 06/11/2018

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: 11/30/2016
• Device Catalogue Number: 366882
• Device Lot Number: 5330687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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