MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367878
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2020
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.(b)(4).
Event or Problem Description
It was reported with the use of the bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes experienced foreign matter in tube; biological and non-biological.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated "the following issue was found in tubes (367929) from lot 0072531: spot in tube x2.".
Additional Manufacturer Narrative
H6: investigation summary bd received 2 samples and 4 photos from the customer for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was not observed as all product specifications were met.Based on the investigation, the most likely root cause is that the embedded fm is indicative of resin colorant and/or resin adhering to the interior of the mold core and breaking free during production.This would typically be seen during the start of a run, or if the mold had to be stopped for maintenance and then restarted.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.
Event or Problem Description
It was reported with the use of the bd vacutainer® lithium heparinn (lh) 158 usp units blood collection tubes experienced foreign matter in tube; biological and non-biological.This event occurred 2 times.The following information was provided by the initial reporter: the customer stated "the following issue was found in tubes (367929) from lot 0072531: spot in tube x2.".

• Brand Name: BD VACUTAINER LITHIUM HEPARINN (LH) 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: 10773265
• Report Number: 1917413-2020-01045
• Device Sequence Number: 13731685
• Product Code: JKA
• UDI-Device Identifier: 50382903678780
• UDI-Public: 50382903678780
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: 367878
• Device Catalogue Number: 367929
• Device Lot Number: 0072531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1