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

Catalog Number	367964
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes, there is gel smearing of 3 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer states gel clumping post centrifugation after tube was place in refrigerator.Gel looks like it is swelling and rbcs are being absorbed into gel.".
Additional Manufacturer Narrative
D.1.Medical device brand name: bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd vacutainer® pst¿ gel and lithium heparinn (lh) 126 units blood collection tubes, there is gel smearing of 3 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer states gel clumping post centrifugation after tube was place in refrigerator.Gel looks like it is swelling and rbcs are being absorbed into gel.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 5 samples and 2 photos for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation (rbc's in gel) was observed.Retention samples were inspected with no issues identified.Additionally, the customer samples were functionally tested.The samples were tested and upon completion, the indicated failure mode for poor barrier separation (rbc's in gel) was observed.There were no difficulties encountered during blood collection and all tubes exhibited proper fill.Bd was able to duplicate the customer¿s indicated failure mode (poor barrier separation-red blood cells in gel) because the defect was evident in the testing of the complaint lot samples.Replicates of customer returned samples showed a significant degree of the defect albeit less than what is depicted in the customer provided photos.All other visual observations of both customer and control samples tested demonstrated clinically acceptable performance.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 has been confirmed for poor barrier separation (rbc's in gel).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.The following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on: 07-sept-2023.

• 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: 17568817
• Report Number: 1917413-2023-00817
• Device Sequence Number: 6683755
• Product Code: JKA
• UDI-Device Identifier: 50382903679640
• UDI-Public: 50382903679640
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 08/31/2023
• Device Catalogue Number: 367964
• Device Lot Number: 2227146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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