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

Model Number	367963
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 19 bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes contained foreign matter.The following information was provided by the initial reporter: "following issues were found in tubes (367963) from lot 0258353: fm in gel ×12, damaged tube ×2, dirty cap ×2, dirty tube ×3".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-19.H6: investigation summary: bd received 12 samples and 6 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter, embedded foreign matter in shield, and damage with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and confirmed 12 tubes which had foreign matter in the gel, 2 tubes that were damaged, 2 caps that were dirty, and 3 tubes that were dirty.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 that 19 bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes contained foreign matter.The following information was provided by the initial reporter: "following issues were found in tubes (367963) from lot 0258353: fm in gel ×12, damaged tube ×2, dirty cap ×2, dirty tube ×3".

• Brand Name: BD VACUTAINER PST GEL AND 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: 11375979
• Report Number: 1917413-2021-00138
• Device Sequence Number: 17153142
• Product Code: JKA
• UDI-Device Identifier: 50382903679633
• UDI-Public: 50382903679633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/05/2021

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: 09/30/2021
• Device Model Number: 367963
• Device Catalogue Number: 367963
• Device Lot Number: 0258353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1