MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367393

Device Problem Filling Problem (1233)

Patient Problem Pain (1994)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type/name is as follows: medical device type: fpa.Common device name: intravascular administration set.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 collection with bd vacutainer® ultratouch¿ push button blood collection set for 2 patients there was insufficient blood flow.There was increased pain and time to complete collection.The following information was provided by the initial reporter, translated from french to english: the nurse needs to collect 15 tubes from a patient with good venous function.During the third sampling, it was impossible to fill the tube without exerting a lot of pressure on it and the pump body had to be pushed in very hard so that the sampling could be carried out.The problem was repeated in a 2nd patient.Clinical consequences and current status of the patient or person involved: increased time to perform the time to take the sample.Less precise gesture due to pain to exert strong pressure over a long period.Actions taken in the institution: needle retained, but not the pump body.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• 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: 16138979
• MDR Text Key: 307116405
• Report Number: 1024879-2023-00013
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673938
• UDI-Public: (01)50382903673938
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153309
• 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
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 367393
• Device Catalogue Number: 367393
• Device Lot Number: 1298781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2021
• 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