MAUDE Adverse Event Report: BECTON DICKINSON EVACUATED BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 307426

Device Problem Short Fill (1575)

Patient Problem Swelling/ Edema (4577)

Event Date 10/08/2023

Event Type  malfunction  

Event Description

It was reported that during use with the evacuated blood collection tube, the tubes underfilled.There was no report of impact to patient or user.The following information was provided by the initial reporter, translated from chinese: the patient was admitted to the hospital for treatment due to schizophrenia.On (b)(6) 2023, a routine blood collection examination was performed after admission.When the nurse used a vacuum blood collection tube to collect blood from the patient, she found that the negative pressure of the vacuum blood collection tube was insufficient, and the blood collection volume was insufficient.After adjusting the blood collection volume multiple times, the patient was still it is insufficient and cannot be used to collect blood from the patient normally.Disposal: immediately stop using and discard the blood collection tube, replace it with a new vacuum blood collection tube, and collect blood from the patient again, and the blood collection goes smoothly.This adverse event caused redness, swelling and pain at the original puncture site as a result of the second puncture.

Manufacturer Narrative

There are multiple bd locations where this device may have been manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacturer report number.D4.Medical device expiration date: unknown.E1.Initial reporter address: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 2243072-2023-01948 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that during use with the evacuated blood collection tube, the tubes underfilled.There was no report of impact to patient or user.The following information was provided by the initial reporter, translated from chinese: the patient was admitted to the hospital for treatment due to schizophrenia.On (b)(6) 2023, a routine blood collection examination was performed after admission.When the nurse used a vacuum blood collection tube to collect blood from the patient, she found that the negative pressure of the vacuum blood collection tube was insufficient, and the blood collection volume was insufficient.After adjusting the blood collection volume multiple times, the patient was still it is insufficient and cannot be used to collect blood from the patient normally.Disposal: immediately stop using and discard the blood collection tube, replace it with a new vacuum blood collection tube, and collect blood from the patient again, and the blood collection goes smoothly.This adverse event caused redness, swelling and pain at the original puncture site as a result of the second puncture.

• Brand Name: EVACUATED BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 18016620
• MDR Text Key: 326850389
• Report Number: 2243072-2023-01948
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 307426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• 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