MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364314

Device Problem Break (1069)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported before use of the bd vacutainer® blood collection tube buffered sodium citrate the cannula/needle had fallen off.The following information was provided by the initial reporter.The customer stated: "the nurse followed the doctor's advice to collect arterial blood for the patient for blood gas analysis.When checking the package before using the arterial blood collection device, it was found that the needle fell off and could not be used.Immediately replaced another arterial blood collection device.Cause harm to the patient.".

Manufacturer Narrative

Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to loose iv cannula 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.This complaint is unable to be confirmed for the indicated failure mode loose iv cannula.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported before use of the bd vacutainer® blood collection tube buffered sodium citrate the cannula/needle had fallen off.The following information was provided by the initial reporter.The customer stated: "the nurse followed the doctor's advice to collect arterial blood for the patient for blood gas analysis.When checking the package before using the arterial blood collection device, it was found that the needle fell off and could not be used.Immediately replaced another arterial blood collection device.Cause harm to the patient.".

Manufacturer Narrative

The following fields have been updated: 2 photos were provided for re-investigation.Imdrf annex b grid (1): b15 - analysis of data provided by user/third party; imdrf annex c grid (1): c16 - manufacturing process problem identified; imdrf annex d grid (1): d15 - cause not established.H.6.Investigation summary: "material #: 364314; lot/batch #: 2091549.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for missing needle was observed.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of missing needle 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 missing needle.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.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBE BUFFERED SODIUM CITRATE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16108898
• MDR Text Key: 308536678
• Report Number: 9617032-2022-01365
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022426
• 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: 01/03/2024

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: 04/30/2024
• Device Catalogue Number: 364314
• Device Lot Number: 2091549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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