MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K3 EDTA (K3E) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366450
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to stopper pullout 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.
Event or Problem Description
It was reported that the bd vacutainer® k3 edta (k3e) blood collection tube did not meet the mean force specification for stopper removal/loose closure before use during r&d testing.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: during r&d testing, we observed some tubes with 2nd time stopper removal forces that did not meet the minimum force specification.We also observed 1 batch of tubes that did not meet the mean force specification.The product information is listed below.Catalog #366430, batch #9095718, test date: (b)(6) 2019, data review date: 14 oct 2019.Observation did not meet minimum force specification.366668, 9122779, (b)(6) 2019, 14 oct 2019.Did not meet minimum force specification.367729, 9184898, (b)(6) 2019, 14 oct 2019.Did not meet minimum force specification.366450, 9095722, (b)(6) 2019, 14 oct 2019.Did not meet mean force specification.

• Brand Name: BD VACUTAINER® K3 EDTA (K3E) 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: 9250805
• Report Number: 1917413-2019-02267
• Device Sequence Number: 16994976
• Product Code: JKA
• UDI-Device Identifier: 50382903664509
• UDI-Public: 50382903664509
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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
• Report Date (Section B): 10/16/2019

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: 04/30/2021
• Device Catalogue Number: 366450
• Device Lot Number: 9095722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/29/2019
• 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