MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH K2E (K2EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Model Number 365974

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: this complaint is associated to field action # 2243072-05/09/2019-007-r.Bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, the customer's indicated failure mode for clotting was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through capa # (b)(4) and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Root cause description a capa # (b)(4) was conducted to document further investigation and root cause analysis relating to this issue.The investigation has identified the most likely root causes and corrective actions are in the process of being implemented.Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.Additional investigation information for recall: 1.Recall summary.--------------------- bd is conducting a voluntary medical device recall for multiple lots of the bd microtainer® tube w/ bd microgardtm closure, k2edta additive, based on confirmed complaints of reduced within the tube reservoir.2.Product and scope: ------------------------- bd microtainer® tube w/ bd microgardtm closure, k2edta additive, catalog# 365974, are used to collect, transport and store skin puncture blood specimens for hematology tests, or for tests utilizing serum or heparinized plasma.3.Description of issue: ------------------------- the referenced lots have been confirmed to have reduced or no additive within the tube reservoir.Bd pas identified this issue thru the bd complaint investigation system.4.Summary table of the # of complaints and mdrs in scope.------------------------------------------------------------------- per 806 # 2243072-05/09/2019-007-r dated june 5, 2019 there were a total of 2 complaints and 2 mdrs within scope at the time the field action was made.5.Hhe summary: -------------------------------- this issue may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes.As a result, this may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.Additionally, if a micro clot is undetected, it may contribute to inaccurate cell counts including platelet, and hemoglobin levels that could potentially produce erroneous results that impact patient treatment.This may lead to moderate health hazard to patients.6.Investigation summary: --------------------------------------- evaluation of complaint samples confirmed that additive was not visually present inside the tubes.Subsequently, retention lot samples from prior and post manufacture of the complaint lot were tested and confirmed the defect was limited to 13 lots manufactured from january 2019 to february 2019.Bd pas has initiated capa (b)(4) to further investigate this issue and implement corrective actions.7.Recall reference #, either bd internal or res/z# bd recall # pas-19-1526.

Event Description

It was reported that after use clotting occurred with a bd microtainer® tubes with k2e (k2edta).The following information was provided by the initial reporter: it is reported customer observed several occurrences of samples clotting.Customer is unsure how long specimen was left sitting or order of draw but specimens were not sent for testing.Specimens that clotted were discarded and she confirmed having unused tubes from the same lot to send in for investigation.They have pulled this specific lot from inventory and haven't experienced any clotting issues since using a different lot number.

Event Description

It was reported that after use clotting occurred with a bd microtainer® tubes with k2e (k2edta).The following information was provided by the initial reporter: it is reported customer observed several occurrences of samples clotting.Customer is unsure how long specimen was left sitting or order of draw but specimens were not sent for testing.Specimens that clotted were discarded and she confirmed having unused tubes from the same lot to send in for investigation.They have pulled this specific lot from inventory and haven't experienced any clotting issues since using a different lot number.

Manufacturer Narrative

Investigation summary: this complaint is associated to field action # 2243072-05/09/2019-007-r.Bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode relating to clotting with the incident lot was observed.Additionally, retention samples were selected from bd inventory for evaluation/testing and upon completion, the customer's indicated failure mode for clotting was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.

Event Description

It was reported that after use clotting occurred with a bd microtainer® tubes with k2e (k2edta).The following information was provided by the initial reporter: it is reported customer observed several occurrences of samples clotting.Customer is unsure how long specimen was left sitting or order of draw but specimens were not sent for testing.Specimens that clotted were discarded and she confirmed having unused tubes from the same lot to send in for investigation.They have pulled this specific lot from inventory and haven't experienced any clotting issues since using a different lot number.

• Brand Name: BD MICROTAINER® TUBES WITH K2E (K2EDTA)
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9437934
• MDR Text Key: 176275085
• Report Number: 2618282-2019-00286
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903659741
• UDI-Public: 50382903659741
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Model Number: 365974
• Device Catalogue Number: 365974
• Device Lot Number: 9052823
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2243072-05/09/2019-007-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other