MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367986

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(4).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with bd vacutainer® sst¿ blood collection tubes the tube was discovered to have cracks.There was no patient or user impact.The following information was provided by the initial reporter, translated from chinese to english: phase: during blood collection.Defect: the case where the pipe body is found to have cracks.Quantity: 1 piece.Effects: no effect on patients and users.

Event Description

It was reported that during use with bd vacutainer® sst¿ blood collection tubes the tube was discovered to have cracks.There was no patient or user impact.The following information was provided by the initial reporter, translated from chinese to english: phase: during blood collection defect: the case where the pipe body is found to have cracks quantity: (b)(4).Effects: no effect on patients and users.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and a crack in the side of the tube was observed.30 retain samples were subject to a visual inspection for damages (cracks, scratches, holes, etc.).All samples passed testing with no presence of damage on any of the 30 tubes.In addition, 10 retention samples underwent a brittleness test to determine the stiffness of the tubes in order to determine if the tube's mechanical properties would lead to breakage/cracking of the tubes during centrifugation.All 10 samples passed the brittleness test, showing no evidence of breakage.Therefore, bd is unable to duplicate the customer reported defect through retain testing.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 a broken/cracked tube based on the photos provided.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16898987
• MDR Text Key: 314923784
• Report Number: 1024879-2023-00286
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: (01)50382903679862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 2278256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1