MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	368661
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 tube push off occurred with a bd vacutainer® k2 edta (k2e) 10.8 mg blood collection tubes.The following information was provided by the initial reporter, "it was reported that the tubes are spontaneously disengaging from multi-sample needles.Tubes spontaneously disengage from multi-sample needles, expiration dates are 08/2019.These items are used by 2 different programs so we hadn't realized they were a manufacturing problem until now.Would like to exchange for tubes with 2021 or later, expiration date, please.6.0 ml lavenders: lot: 8156830.Exp: 11/30/2019 ¿ 9 boxes.Complaint 1 of 5.
Event or Problem Description
It was reported that tube push off occurred with a bd vacutainer® k2 edta (k2e) 10.8 mg blood collection tubes.The following information was provided by the initial reporter, "it was reported that the tubes are spontaneously disengaging from multi-sample needles.Tubes spontaneously disengage from multi-sample needles, expiration dates are 8/2019.These items are used by 2 different programs so we hadn't realized they were a manufacturing problem until now.Would like to exchange for tubes with 2021 or later, expiration date, please.6.0ml lavenders: lot: 8156830 exp: 11/30/2019 ¿ 9 boxes.Complaint 1 of 5.
Additional Manufacturer Narrative
Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.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.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 10.8 MG 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: 8632732
• Report Number: 1917413-2019-01508
• Device Sequence Number: 2211976
• Product Code: JKA
• UDI-Device Identifier: 50382903686617
• UDI-Public: 50382903686617
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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: 11/30/2019
• Device Catalogue Number: 368661
• Device Lot Number: 8156830
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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