MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SSTTM II ADVANCE TUBES; BLOOD COLLECTION TUBE.

Catalog Number	366882
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: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 broken tube cap with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers¿ indicated failure mode.
Event or Problem Description
It was reported that "bd vacutainer® ssttm ii advance tube had a broken cap.No serious injury, no medical interventions.Problem was noticed before use.

• Brand Name: BD VACUTAINER® SSTTM II ADVANCE TUBES
• Common Device Name: BLOOD COLLECTION TUBE.
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7058890
• Report Number: 9617032-2017-00177
• Device Sequence Number: 10788607
• Product Code: JKA
• UDI-Device Identifier: 00382903668823
• UDI-Public: 00382903668823
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023331
• 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): 11/09/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 11/27/2017
• 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