MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367935

Device Problem Fracture (1260)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® tube glu plh 13x75 4.0 blblce gr the tube was cracked.This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: "tubes are cracking once they have been removed from cold storage." 23 feb 2023 ¿ rcc reviewed the picture provided and found the tube that contain blood cracked and causing the blood came out.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2166078.Medical device expiration date: 2023-10-31.Device manufacture date: 2022-06-15.Medical device lot #: 1195871.Medical device expiration date: 2022-11-30.Device manufacture date: 2021-07-14.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for cracked tubes was observed.Visual examination of the photos was performed and revealed cracked tubes; however, this product was not stored as recommended.The customer states that the tubes were frozen between the temperature range of -16° to -24°c, being in the freezer for 1-6 days.The instructions for use on the evacuated blood collection system states under the storage for the product, ¿store tubes at 4-25°c (39-77°f).Additionally, retention samples from bd inventory were evaluated by visual examination and the issue of cracked tubes was not observed.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 not been confirmed for the indicated failure mode cracked tubes.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® tube glu plh 13x75 4.0 blblce gr the tube was cracked.This event occurred 8 times.The following information was provided by the initial reporter.The customer stated: "tubes are cracking once they have been removed from cold storage." 23 feb 2023 ¿ rcc reviewed the picture provided and found the tube that contain blood cracked and causing the blood came out.

• Brand Name: BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR
• Type of Device: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16513239
• MDR Text Key: 311237826
• Report Number: 1917413-2023-00181
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367935
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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