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 Code	Overfill (2404)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 11 bd vacutainer® lithium heparin (lh) 56 usp units blood collection tubes experienced overfill during use.The following information was provided by the initial reporter: material no: 366667, batch no: 9095727.Event description per email states, during r&d testing in (b)(4), we have identified instances where the tube draw volume was outside of our specifications.The specific product sku and batch numbers where this occurred are listed below.Event date, awareness date, catalog #, batch #, observation: on (b)(6) 2019, 12 jun 2019, 366667, 9095727, draw volumes above 3.3ml (several tubes with maximum draw 3.31ml).
Event or Problem Description
It was reported that 11 bd vacutainer® lithium heparinn (lh) 56 usp units blood collection tubes experienced overfill during use.The following information was provided by the initial reporter: material no: 366667 batch no: 9095727 event description per email states, during r&d testing in franklin lakes, we have identified instances where the tube draw volume was outside of our specifications.The specific product sku and batch numbers where this occurred are listed below.Event date awareness date catalog # batch # observation (b)(6) 2019 (b)(6) 2019: (b)(6).Draw volumes above 3.3ml (several tubes with maximum draw 3.31ml).
Additional Manufacturer Narrative
Correction: g.4 date received by manufacturer: 6/12/2019.
Event or Problem Description
It was reported that 11 bd vacutainer® lithium heparin (lh) 56 usp units blood collection tubes experienced overfill during use.The following information was provided by the initial reporter: material no: 366667 batch no: 9095727.Event description per email states, during r&d testing in franklin lakes, we have identified instances where the tube draw volume was outside of our specifications.The specific product sku and batch numbers where this occurred are listed below.Event date: (b)(6) 2019, awareness date: 12 jun 2019, catalog # 366667, batch # 9095727.Observation: draw volumes above 3.3ml (several tubes with maximum draw 3.31ml).
Additional Manufacturer Narrative
H.6.Investigation: investigation summary: bd received samples from the customer facility for investigation.The samples were tested/evaluated and the customer's indicated failure mode for overfill with the incident lot was not observed as no tubes filled beyond its specification limits.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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for overfill with the incident lot was not observed as no tubes filled beyond its specification limits.Root cause description: based on the investigation, a root cause could not be determined.No product was found to be have over filled past the specifications limits.Rationale: based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.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 business team regularly reviews the collected data for identification of emerging trends.

• 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: 8748920
• Report Number: 1917413-2019-01680
• Device Sequence Number: 2398395
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2019

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: 08/31/2020
• Device Catalogue Number: 366667
• Device Lot Number: 9095727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019; 06/12/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/01/2019; 08/05/2019
• 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