MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367855
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/08/2017
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.
Event or Problem Description
It was reported that bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes had low draw.
Additional Manufacturer Narrative
Investigation summary: the device history records for batch 6029881 have been reviewed with no issues being identified.Bd pas acknowledges that the customer has had an issue with the incident lot, but for plant evaluation purposes, the complaint was not observed due to a lack of objective evidence.Based on the severity and occurrence of the reported condition there will be no further actions.Review of the event description confirmed pic (b)(4) (no or low draw volume) was appropriate.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd pas business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes had low draw.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7462543
• Report Number: 1917413-2018-00973
• Device Sequence Number: 19261671
• Product Code: GIM
• UDI-Device Identifier: 50382903678551
• UDI-Public: 50382903678551
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: 06/30/2017
• Device Catalogue Number: 367855
• Device Lot Number: 6029881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 09/05/2018
• 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