MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367835
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the device experienced coagulated/clogged tubes.This event occurred two times.The following information was provided by the initial reporter.The customer stated: for more than 1 month customer has observed that both hematology counters and coagulometers that pierce the rubber from stoppers of tubes containing the samples to be analyzed, instead of going through them, in some cases produce a punching effect (coring).It causes the clogging of piercing needles and the sampling needles as well, causing the immediate stoppage of the equipment and the continuous call for technical service, so as well causes a delay caused by solving this problem.The event frequency is randomly.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd received 4 photos from the customer in support of this complaint.The photos were evaluated and the customer's indicated failure mode of coring was observed as the photos do show pieces of lavender material consistent with the stopper.Additionally, 100 retentions samples from the bd inventory were inspected with no issues being identified and, 10 production lot in-house retention tubes samples were draw tested.All tubes were within specification limits and coring was not observed.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, was not able to be duplicated in the retention samples.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: bd received 4 photos from the customer in support of this complaint.The photos were evaluated and the customer's indicated failure mode of coring was observed as the photos do show pieces of lavender material consistent with the stopper.Additionally, 100 retentions samples from the bd inventory were inspected with no issues being identified and, 10 production lot in-house retention tubes samples were draw tested.All tubes were within specification limits and coring was not observed.Bd was able to confirm the customer¿s indicated failure mode with the photos provided; however, was not able to be duplicated in the retention samples.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes, the device experienced coagulated/clogged tubes.This event occurred two times.The following information was provided by the initial reporter.The customer stated: for more than 1 month customer has observed that both hematology counters and coagulometers that pierce the rubber from stoppers of tubes containing the samples to be analyzed, instead of going through them, in some cases produce a punching effect (coring).It causes the clogging of piercing needles and the sampling needles as well, causing the immediate stoppage of the equipment and the continuous call for technical service, so as well causes a delay caused by solving this problem.The event frequency is randomly.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13388817
• Report Number: 1917413-2022-00027
• Device Sequence Number: 16598658
• Product Code: JKA
• UDI-Device Identifier: 50382903678353
• UDI-Public: 50382903678353
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 367835
• Device Catalogue Number: 367835
• Device Lot Number: 1165617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown