MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.11; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367922
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported prior to using bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes that thirteen (13) tubes had additive that was not distributed evenly and abnormally white.There was no health impact or consequence reported.
Additional Manufacturer Narrative
D1.Medical device brand name: bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes.Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for additive abnormality with the incident lot was not observed.Additive appeared to be adhering to the tube wall, but this is not an unusual appearance for the powder additive.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to additive abnormality as all samples met specifications.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 of additive abnormality.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: SEE H.11
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20181191
• Report Number: 1917413-2024-00848
• Device Sequence Number: 8704577
• Product Code: JKA
• UDI-Device Identifier: 30382903679226
• UDI-Public: (01)30382903679226(11)240313(17)250731(10)4073042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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: 07/31/2025
• Device Catalogue Number: 367922
• Device Lot Number: 4073042
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2024
• 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