MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number	366703
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter email: (b)(6).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 when using the bd vacutainer® no additive (z) tube, the device experienced missing additive.The following information was provided by the initial reporter.The customer stated: after multiple attempts of contact no further information was provided, setting this case to pc.366703 tube pln plh 13x75 3.0 small amount of serum obtained.
Event or Problem Description
It was reported when using the bd vacutainer® no additive (z) tube, the device experienced missing additive and there was poor barrier separation.The following information was provided by the initial reporter.The customer stated: after multiple attempts of contact no further information was provided, setting this case to pc.366703 tube pln plh 13x75 3.0 small amount of serum obtained.
Additional Manufacturer Narrative
The following field has been updated with additional information; b.5.Describe event or problem: it was reported that after centrifugation with bd vacutainer® no additive (z) tube, the device experienced missing additive and there was poor barrier separation.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that specimens are clotting and after centrifugation only a small amount of serum is left.H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were visually inspected with no issues being identified 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.Bd was unable to duplicate or confirm the customer¿s indicated failure (clotting and poor serum) because the alleged defect is invalid.No clinical testing is required because the product is not being used within the product claims.This complaint is not confirmed with respect to clotting/fibrin and poor serum.The root cause for the issues reported is improper use of the material.This tube is not for serum collection.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.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• 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: 16127353
• Report Number: 1917413-2023-00017
• Device Sequence Number: 16940984
• Product Code: FMH
• UDI-Device Identifier: 00382903667031
• UDI-Public: 00382903667031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 04/20/2023

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: 07/31/2023
• Device Catalogue Number: 366703
• Device Lot Number: 2018830
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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