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

Catalog Number	367922
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.1 medical device brand name: bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes h.3.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 while using the bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes that there was discolored / abnormal additive form.The following information was provided by the initial reporter: have the issue presented on different lot numbers? all past deliveries contained the white powder inside the tube, but not solidified.Have these tube been used to draw blood from patients? no how are the tubes being stored? inside the boxes sent by the distributor in our temperature controlled warehouse (15 - 25 c).Has the issue presented on every tube from the lot? yes customer is concern in regards to the additive appearance on lot#: 3074286.The powder seems to be clumping."the white powder inside of most the vacutainer tubes seems to be solidified".
Additional Manufacturer Narrative
H.6.Investigation summary: bd did not received samples, but 6 photos were provided for investigation.The photos were reviewed and the indicated failure mode for additive appearance with the incident lot was not observed.The photos were evaluated and show that additive is present in the tubes and is clinging to the inside of the tube wall along the length of the tube.This type of powder can exhibit come "clinging" properties; this is not an unusual appearance additionally, 100 retention samples from bd inventory were evaluated and no issues were observed relating to additive appearance 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 additive appearance.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported that while using the bd vacutainer® sodium fluoride 10mg potassium oxalate 8 mg (fx) blood collection tubes that there was discolored / abnormal additive form.The following information was provided by the initial reporter: ¿ have the issue presented on different lot numbers? all past deliveries contained the white powder inside the tube, but not solidified.¿ have these tube been used to draw blood from patients? no ¿ how are the tubes being stored? inside the boxes sent by the distributor in our temperature controlled warehouse (15 - 25 c).¿ has the issue presented on every tube from the lot? yes customer is concern in regards to the additive appearance on lot#: 3074286.The powder seems to be clumping."the white powder inside of most the vacutainer tubes seems to be solidified".

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17431315
• Report Number: 1917413-2023-00702
• Device Sequence Number: 8884834
• Product Code: JKA
• UDI-Device Identifier: 50382903679220
• UDI-Public: 50382903679220
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/22/2023

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: Other
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 367922
• Device Lot Number: 3074286
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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