MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® ONE USE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364815

Device Problem Obstruction of Flow (2423)

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

Event Date 12/08/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® one use holder it was difficult to eject the needle from the holder/needle stays blocked askew.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when preparing the material, the nurse noticed the pump body that fits on the sampling needle is defective.The insertion area is blocked.The nurse puts another pump body in its place.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(6), nj has been listed in sections manufacturer name, city, state and mfr site the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: no expiration date for this device 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.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2023-02-21.H.6.Investigation summary: bd received 2 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for unable to attach was observed.One of the samples has flash (excess plastic) in the threaded area and the other sample has a threaded area with an incomplete mold.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint has been confirmed for the indicated failure mode unable to attach due to molding defects.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® one use holder it was difficult to eject the needle from the holder/needle stays blocked askew.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when preparing the material, the nurse noticed the pump body that fits on the sampling needle is defective.The insertion area is blocked.The nurse puts another pump body in its place.".

• Brand Name: BD VACUTAINER® ONE USE HOLDER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16140889
• MDR Text Key: 308736746
• Report Number: 2243072-2023-00006
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903648158
• UDI-Public: 50382903648158
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAMENDMENT
• 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: 02/23/2023

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 Model Number: 364815
• Device Catalogue Number: 364815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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