MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367355

Device Problem Failure to Disconnect (2541)

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

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this.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 when using the bd vacutainer® push button blood collection set with pre-attached holder, the user identified the device does not detach from the holder.The following information was provided by the initial reporter.The customer stated: we have two problems: the vacu-body does not disassemble easily, a pair of pliers is needed.The biomerieux blood culture vacuums on the market do not fit easily and they move.As a result, the nurse are tempted not to use a vacutainer, which is a big step backwards.

Manufacturer Narrative

H.6.Investigation summary: no customer samples or photos were received for evaluation.As no customer samples or photos were received the scope of this investigation is limited and retains cannot be tested as the batch number is unknown.Due to an unknown batch number and the unavailability of customer samples, the root cause is indeterminate.A review of the dhr could not be performed as the batch number is unknown.

Event Description

It was reported when using the bd vacutainer® push button blood collection set with pre-attached holder, the user identified the device does not detach from the holder.The following information was provided by the initial reporter.The customer stated: we have two problems: - the vacu-body does not disassemble easily, a pair of pliers is needed - the biomerieux blood culture vacuums on the market do not fit easily and they move.As a result, the nurse are tempted not to use a vacutainer, which is a big step backwards.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• 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: 15566431
• MDR Text Key: 305805914
• Report Number: 1024879-2022-00593
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K011984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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 Catalogue Number: 367355
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/09/2022
• 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