MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367842
Medical Device Problem Code	Overfill (2404)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
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 overfill occurred during use with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.The following information was provided by the initial reporter, "it was reported that the product was found to have draw volume greater than the upper spec limit of 5.5ml.Upon data analysis and review, product for one lot of 367842 was found to have draw volume greater than the upper spec limit of 5.5ml.2 failure of 30 tested.Product is required to meet 99% reliability with 95% confidence against the usl, but a statistical analysis shows that this lot is unlikely to be meeting that requirement.Ppk requirement is = 1.02 for a sample size of 30.This lot has a ppk of 0.50.Product was exposed to a double dose of sterilization.Min dose: 15.6kgy.Max dose: 21.8kgy.R&d senior manager performing data analysis and review of tube 367842, and the draw volume was greater than the upper spec limit of 5.5ml, so it was overfilling.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.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.
Event or Problem Description
It was reported that overfill occurred during use with a bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes.The following information was provided by the initial reporter."it was reported that the product was found to have draw volume greater than the upper spec limit of 5.5ml.Upon data analysis and review, product for one lot of 367842 was found to have draw volume greater than the upper spec limit of 5.5ml.2 failure of 30 tested.Product is required to meet 99% reliability with 95% confidence against the usl, but a statistical analysis shows that this lot is unlikely to be meeting that requirement.Ppk requirement is = 1.02 for a sample size of 30.This lot has a ppk of 0.50.Product was exposed to a double dose of sterilization min dose: 15.6kgy, max dose: 21.8kgy.R&d senior manager performing data analysis and review of tube 367842, and the draw volume was greater than the upper spec limit of 5.5ml, so it was overfilling.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10002100
• Report Number: 1917413-2020-00411
• Device Sequence Number: 11342904
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 367842
• Device Catalogue Number: 367842
• Device Lot Number: 9065784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 04/28/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown