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 Shielding Failure (1568)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set, the user identified the sleeve falling off from the device.The following information was provided by the initial reporter.The customer stated: during blood culture collection, the cork-boring needle of the protected epicranial needle used to pierce the tubes was stripped of its protective sleeve.As a result, the patient's blood flowed through the needle.

Manufacturer Narrative

There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.Lot #: batch 2045597 does not exist for material 367393.Expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set, the user identified the sleeve falling off from the device.The following information was provided by the initial reporter.The customer stated: during blood culture collection, the cork-boring needle of the protected epicranial needle used to pierce the tubes was stripped of its protective sleeve.As a result, the patient's blood flowed through the needle.

Manufacturer Narrative

H6: investigation summary bd did not receive samples or photographs from the customer in support of this complaint.Batch: 2045597 provided in support of this complaint is not correct therefore evaluation of retention samples cannot be completed.Bd was unable to duplicate or confirm the customer¿s indicated failure mode.No root cause could be established for the reported defect.The device history records could not be reviewed because lot number is not correct.H3 other text : see h10.

• 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: 14389287
• MDR Text Key: 292600396
• Report Number: 1024879-2022-00265
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673938
• UDI-Public: 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,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367393
• Device Catalogue Number: 367393
• Device Lot Number: 2045597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• 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