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

Model Number	368056
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2020
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.(b)(4).
Event or Problem Description
It was reported before use the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes had foreign matter in tube; biological and non-biological.This event occurred 6 times.The following information was provided by the initial reporter: the customer "witnessed black chunks in vacutainer.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/14/2020.H.6.Investigation: bd received 5 samples and 1 photo from the customer for investigation.The photo was reviewed and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, all 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 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 non-conformances during manufacturing of the product.
Event or Problem Description
It was reported before use the bd vacutainer® pst¿ gel and lithium heparinn (lh) 65 units blood collection tubes had foreign matter in tube; biological and non-biological.This event occurred 6 times.The following information was provided by the initial reporter: the customer "witnessed black chunks in vacutainer.".

• Brand Name: BD VACUTAINER PST GEL AND LITHIUM HEPARINN (LH) 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: 10549145
• Report Number: 1917413-2020-00835
• Device Sequence Number: 1270362
• Product Code: JKA
• UDI-Device Identifier: 50382903680561
• UDI-Public: 50382903680561
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 04/30/2021
• Device Model Number: 368056
• Device Catalogue Number: 367961
• Device Lot Number: 0100294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/16/2020
• 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