MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ONE USE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364815

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from your facility for evaluation.Additionally, we were unable to determine the specific catalog or lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.

Event Description

It was reported when using the bd vacutainer® one use holder, the device experienced failure to minimize exposure to blood and sharps during blood collection.This event occurred once.The following information was provided by the initial reporter.The customer stated: customer problem: customer states tubes are falling out of stackable holder, product 364815.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from your facility for evaluation.Additionally, we were unable to determine the specific catalog or lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.

Event Description

It was reported when using the bd vacutainer® one use holder, the device experienced failure to minimize exposure to blood and sharps during blood collection.This event occurred once.The following information was provided by the initial reporter.The customer stated: customer problem: customer states tubes are falling out of stackable holder, product 364815.

• Brand Name: BD VACUTAINER® ONE USE HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15544438
• MDR Text Key: 302286416
• Report Number: 1917413-2022-00624
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903648153
• UDI-Public: 00382903648153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• 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