MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367842
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3 bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced under fill or low draw of a tube with blood during use.The following information was provided by the initial reporter: material no.367842 batch no.Unknown.Customer complained about tubes not filling completely.
Additional Manufacturer Narrative
Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.However, bd has initiated further investigation relating to this issue through capa#260774 and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.
Event or Problem Description
It was reported that 3 bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced under fill or low draw of a tube with blood during use.The following information was provided by the initial reporter: material no.367842.Batch no.Unknown.Customer complained about tubes not filling completely.
Event or Problem Description
It was reported that 3 bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced under fill or low draw of a tube with blood during use.The following information was provided by the initial reporter: material no.367842, batch no.Unknown.Customer complained about tubes not filling completely.
Additional Manufacturer Narrative
The following information has been updated: g.5.Date received by manufacturer: 2019-11-14.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9355982
• Report Number: 1917413-2019-02398
• Device Sequence Number: 13576080
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 367842
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/14/2019; 11/14/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/09/2019; 12/12/2019
• 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