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

Catalog Number 367968

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

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 the cap of a bd vacutainer® sst¿ blood collection tubes was deformed.The following information was provided by the initial reporter, translated from chinese to english: deformation of cap.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode of deformed hemogard was observed.Additionally, thirty (30) retention samples from bd inventory were evaluated by visual examination and the issue of deformed hemogard 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 been confirmed for the indicated failure mode deformed hemogard.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that the cap of a bd vacutainer® sst¿ blood collection tubes was deformed.The following information was provided by the initial reporter, translated from chinese to english: deformation of cap.

Manufacturer Narrative

H.6 investigation summary : catalog number: 367968, batch number: 2096006.Bd received 1 sample and 1 photo for investigation.The sample and photo were reviewed and the indicated failure mode for defective shield was observed.In addition, 30 retain samples were subjected to a visual inspection for deformed hemogard shield.0 of 30 retain samples failed the visual inspection for deformed hemogard shield.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 defective shield based on the customer returned sample and photo provided.Retention samples did not show the defect.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.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that the cap of a bd vacutainer® sst¿ blood collection tubes was deformed.The following information was provided by the initial reporter, translated from chinese to english: deformation of cap.

• 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 ; 8015296192
• MDR Report Key: 16262079
• MDR Text Key: 308587973
• Report Number: 1024879-2023-00052
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 04/18/2023

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: 03/31/2023
• Device Catalogue Number: 367968
• Device Lot Number: 2096006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/29/2023
• Supplement Dates Manufacturer Received: 02/01/2023; 04/18/2023
• Supplement Dates FDA Received: 02/08/2023; 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1