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	367880
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd vacutainer® lithium heparin (lh) 158 usp units blood collection tubes had incorrect label information.The following information was provided by the initial reporter: material no: 367880, batch no: unknown.It was reported the information on the unit label is different from what is online.We typically order these bd tubes from (b)(4) and have noticed that although the pn is the same for each, the units of lihep stated on the package label (ordered from (b)(4)) is different than what is stated on the bd website.
Additional Manufacturer Narrative
H.6.Investigation: investigation summary: the inquiry involved a discrepancy between the usp units displayed on a bd website (url: https://www.Bd.Com/en-ca/products/blood-and-urine-specimen-collection/venous-collection/vacutainer-blood-collection-tubes/view-chemistry-tubes) and the heparin unit label.The unit label has 158 usp printed on it and is correct (per the unit label drawing), while the bd site has 150 usp.Investigation conclusion: the unit label for the product is accurate, while the bd site is inaccurate.Root cause description: the bd site is inaccurate.The exact root cause could not be determined; however, there is no issue with the unit label.Rationale: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.However, the bd site has been updated to display the correct units, per the unit label drawing.H3 other text : see h.10.
Event or Problem Description
It was reported that bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes had incorrect label information.The following information was provided by the initial reporter: material no: 367880 batch no: unknown.It was reported the information on the unit label is different from what is online.We typically order these bd tubes from vwr and have noticed that although the pn is the same for each, the units of lihep stated on the package label (ordered from vwr) is different than what is stated on the bd website.

• 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: 8683807
• Report Number: 1917413-2019-01581
• Device Sequence Number: 11173776
• Product Code: JKA
• UDI-Device Identifier: 50382903678803
• UDI-Public: 50382903678803
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• 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): 07/09/2019

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: 367880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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