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 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 two bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced overfill during use.The following information was provided by the initial reporter: it was reported that during r&d testing in bd franklin lakes, instances were identified where the tube draw volume was outside of the specifications.Draw volumes were above 2.2ml (2.21 & 2.23ml) event description per initial reporter email states, during r&d testing, 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, 367841, 9065784, draw volumes above 2.2ml (2.21 & 2.23ml).
Additional Manufacturer Narrative
H.6.Investigation: investigation summary: samples were evaluated and tested and upon completion, no issues were observed relating to overfill as all samples met specifications.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 retain and customer samples, the indicated failure mode for overfill with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Rationale: 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.H3 other text : see h.10.
Event or Problem Description
It was reported that two bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes experienced overfill during use.The following information was provided by the initial reporter: it was reported that during r&d testing in bd franklin lakes, instances were identified where the tube draw volume was outside of the specifications.Draw volumes were above 2.2ml (2.21 & 2.23ml) event description per initial reporter email states, during r&d testing, 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 #: 367841, batch #: 9065784, observation: draw volumes above 2.2ml (2.21 & 2.23ml).

• 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: 8742146
• Report Number: 1917413-2019-01663
• Device Sequence Number: 1591154
• Product Code: JKA
• UDI-Device Identifier: 50382903678421
• UDI-Public: 50382903678421
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K981013
• 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
• Report Date (Section B): 07/22/2019

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: 06/30/2020
• Device Catalogue Number: 367842
• Device Lot Number: 9065784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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