MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® LITHIUM HEPARINN (LH) 56 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366667
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	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tube underfilled during research and development testing.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: during r&d testing, we observed tubes with a draw volume below our minimum specification.Catalog/batch number information is below.(b)(6).
Event or Problem Description
It was reported that the bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tube underfilled during research and development testing.This complaint was created to capture the 1st of 4 related incidents.The following information was provided by the initial reporter: during r&d testing, we observed tubes with a draw volume below our minimum specification.Catalog/batch number information is below.Catalog # batch # test date data review date 366667 9065768 (b)(6) 2019 (b)(6) 2019 368587 9065849 (b)(6) 2019 (b)(6) 2019 367981 9123804 (b)(6) 2019 (b)(6) 2019 367977 9116677 (b)(6) 2019 (b)(6) 2019.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received samples and a photo from the customer facility for investigation.The photo was evaluated and the customer's indicated failure mode for underfill with the incident lot was observed.However, the received samples were evaluated and tested, and no issues relating to underfill were observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa (b)(4).The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.

• Brand Name: BD VACUTAINER® LITHIUM HEPARINN (LH) 56 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: 8945226
• Report Number: 1917413-2019-01994
• Device Sequence Number: 11300439
• Product Code: JKA
• UDI-Device Identifier: 50382903666671
• UDI-Public: 50382903666671
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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 Expiration Date: 07/31/2020
• Device Catalogue Number: 366667
• Device Lot Number: 9065768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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