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

Model Number	367925
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.The date received by manufacturer has been used for this field.Bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2132113, medical device expiration date: 10/31/2023, and device manufacture date: 05/12/2022.Medical device lot #: unknown, medical device expiration date: unknown, and device manufacture date: unknown.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 by the customer that the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes presented hemolysis.Verbatim: it was reported by the customer that hemolysis occurred.Customer states samples are hemolyzed, several lots showed hemolysis.Customer does not have information on lots affected other than the lot given for this case.Hemolysis occurs if tube is adequality filled or short draw.Tubes vary from few minutes to 30 minutes before centrifuged.Tubes spun at 3800rpm for 5 min.Did the specimen(s) need to be recollected? yes.
Event or Problem Description
It was reported by the customer that the bd vacutainer® sodium fluoride 15mg potassium oxalate 12 mg (fx) blood collection tubes presented hemolysis.Verbatim: it was reported by the customer that hemolysis occurred.Customer states samples are hemolyzed, several lots showed hemolysis.Customer does not have information on lots affected other than the lot given for this case.Hemolysis occurs if tube is adequality filled or short draw.Tubes vary from few minutes to 30 minutes before centrifuged.Tubes spun at 3800rpm for 5 min.Did the specimen(s) need to be recollected? yes.
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 hemolysis were observed.Bd was unable to confirm the customer¿s indicated failure (hemolysis) because the defect was not evident in the testing of the complaint lot samples.All parameters of both 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 unable to be confirmed for the indicated failure mode hemolysis.Bd was not able to identify a root cause for the indicated failure mode.Factors that may contribute to hemolysis 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.

• 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 ; 8015296192
• MDR Report Key: 16096137
• Report Number: 1917413-2022-00819
• Device Sequence Number: 17846647
• Product Code: JKA
• UDI-Device Identifier: 50382903679251
• UDI-Public: (01)50382903679251
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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 Expiration Date: 10/31/2023
• Device Model Number: 367925
• Device Catalogue Number: 367925
• Device Lot Number: 2132113
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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