MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367878
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd vacutainer® lithium heparin (lh) 158 usp units blood collection tube experienced confusion between nahep and lihep tubes prior to use.The following information was provided by the initial reporter: material no.367878 batch no.Unknown.Customers complains that it is difficult to distinguish between the 4ml sodium and lithium heparin tubes since the stoppers are identical.They would prefer to have some type of differentiating feature on the stopper to avoid confusion.
Event or Problem Description
It was reported that the bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tube experienced confusion between nahep and lihep tubes prior to use.The following information was provided by the initial reporter: material no: 367878, batch no: unknown.Customers complains that it is difficult to distinguish between the 4ml sodium and lithium heparin tubes since the stoppers are identical.They would prefer to have some type of differentiating feature on the stopper to avoid confusion.
Additional Manufacturer Narrative
H.6.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 158 USP UNITS 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: 9135698
• Report Number: 1917413-2019-02143
• Device Sequence Number: 606845
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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
• Report Date (Section B): 10/02/2019

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: 367878
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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