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

Model Number	366480
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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 when using the bd vacutainer® sodium heparin¿ (nh) blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: there were "particles floating from the cap." when the tubes are upside down they see particles floating from the cap.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but four (4) photos were provided for investigation.Three (3) photos were reviewed and the indicated failure mode for broken tubes/damaged case was observed.One (1) photo was reviewed and foreign matter (fm) was not observed as the picture showed normal additive pellets from the freeze-dried process.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issues of broken tubes and fm were not observed.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.This complaint has been confirmed for the indicated failure mode of broken tubes.However, the complaint could not be confirmed for fm as the tubes met specifications.The exact cause for the broken tubes and damaged case was unable to be determined.
Event or Problem Description
It was reported when using the bd vacutainer® sodium heparin (nh) blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: there were "particles floating from the cap." when the tubes are upside down they see particles floating from the cap.".
Event or Problem Description
It was reported when using the bd vacutainer® sodium heparin¿ (nh) blood collection tube there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: there were "particles floating from the cap." when the tubes are upside down they see particles floating from the cap.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-09-08.H6: investigation summary bd received two hundred (200) samples and four (4) photos for investigation.The samples and photos were reviewed and the indicated failure mode for damaged tubes was observed.A white pellet of dried additive could be seen in the tubes.This is a normal additive appearance from the freeze dried process and is not considered foreign matter (fm) as the material met product specifications.Additionally, one hundred (100) retention samples from bd inventory, were evaluated by visual examination and the issues of damaged tubes and fm were not observed.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.This complaint has been confirmed for the indicated failure mode of damaged tubes.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 12333646
• Report Number: 1917413-2021-00750
• Device Sequence Number: 19943834
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• 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,Followup
• Report Date (Section B): 09/14/2021

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: 03/31/2023
• Device Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: 1074719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 09/14/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/08/2021; 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1