MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366065
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for 132623 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 seditainer¿ 0.105m 1.25ml buffered sodium citrate blood collection tubes had issues with underfill.

• Brand Name: BD SEDITAINER¿ 0.105M 1.25ML BUFFERED SODIUM CITRATE 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: 7494944
• Report Number: 9617032-2018-02328
• Device Sequence Number: 10790415
• Product Code: JKA
• UDI-Device Identifier: 50382903660655
• UDI-Public: 50382903660655
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K953994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 10/31/2017
• Device Catalogue Number: 366065
• Device Lot Number: 6312552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 05/08/2018
• 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