MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM HEPARIN¿ (NH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	366480
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
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 white foreign matter was found in the bd vacutainer® sodium heparin¿ (nh) blood collection tube before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "while on the phone she also admitted the same occurrence happened with a previous shipment (date unknown) of material no.366480, batch no.9036725 (2 of 2).No amount of tubes affected are known for this occurrence.Just like today's instance, incident was before use therefore no erroneous results, no medical intervention, no serious injury, no patient identifiers, no death, no course of treatment change, no exposure to blood, no needle stick and no safety issue.Customer did admit tubes with this lot were simply discarded when witnessed to have fm in them.".
Event or Problem Description
It was reported that white foreign matter was found in the bd vacutainer® sodium heparin¿ (nh) blood collection tube before use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "while on the phone she also admitted the same occurrence happened with a previous shipment (date unknown) of material no.366480, batch no.9036725 (2 of 2).No amount of tubes affected are known for this occurrence.Just like today's instance, incident was before use therefore no erroneous results, no medical intervention, no serious injury, no patient identifiers, no death, no course of treatment change, no exposure to blood, no needle stick and no safety issue.Customer did admit tubes with this lot were simply discarded when witnessed to have fm in them.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for foreign matter with the incident lot was not observed, as the reported matter is additive and intended to be in the tube.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.

• Brand Name: BD VACUTAINER® SODIUM HEPARIN¿ (NH) 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: 9218601
• Report Number: 1917413-2019-02231
• Device Sequence Number: 19375054
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 02/28/2021
• Device Catalogue Number: 366480
• Device Lot Number: 9036725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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