MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367925
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	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes customer provided two lots 2109102 and 2132113, however the customer can not confirm which lot was used on which day.Reporting both lots for each date.The information for each lot number is as follows: medical device lot #: 2109102, medical device expiration date: 30-sep-2023, device manufacture date: 19-apr-2022, medical device lot #: 2132113, medical device expiration date: 31-oct-2023, device manufacture date: 12-may-2022.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 that after use with 4 bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes the samples had clotted.There was no reported patient impact.This is the 4th of 4 occurrences.The following information was provided by the initial reporter: customer is reporting they had few samples that were drawn within days of each other that seem to have clotted.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Therefore, retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues relating to clotting were observed: visual inspection of retention samples was satisfactory, with no issues identified.Additionally, clinical testing was performed: no difficulties were encountered during blood collection and all tubes exhibited proper fill.Bd was unable to duplicate or confirm the customer¿s indicated failure mode (clotting) because the defect was not evident in the testing of the complaint lot samples.The parameters for retain and control samples tested, demonstrated clinically acceptable performance for all visual observations evaluated.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 is not confirmed with respect to clotting.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to clotting were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.
Event or Problem Description
It was reported that after use with 4 bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes the samples had clotted.There was no reported patient impact.(b)(4).The following information was provided by the initial reporter: customer is reporting they had few samples that were drawn within days of each other that seem to have clotted.

• Brand Name: SEE H.10
• 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 ; 8448235433
• MDR Report Key: 16818151
• Report Number: 1917413-2023-00326
• Device Sequence Number: 17923254
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: (01)50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: SEE H.10
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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