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

Model Number 364815

Device Problem Component Incompatible (1108)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device 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 that the tube was "extremely snug" in the bd vacutainer® one use holder during use and had to pushed "extremely hard" to fit onto the non-patient end needle in order to draw up blood.This occurred on 3000 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: ""for the past several months, the customer has been noticing that their 16x100 sst tubes, code number 367988, have been extremely snug when used with bd's single-use holder, 364815.Customer is stating that they have to push extremely hard on the tubes, to ensure that they can get on to the back-end needle, so that the vacuum can pull the blood in to the tube.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, 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.

Event Description

It was reported that the tube was "extremely snug" in the bd vacutainer® one use holder during use and had to pushed "extremely hard" to fit onto the non-patient end needle in order to draw up blood.This occurred on 3000 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "for the past several months, the customer has been noticing that their 16x100 sst tubes, code number 367988, have been extremely snug when used with bd's single-use holder, 364815.Customer is stating that they have to push extremely hard on the tubes, to ensure that they can get on to the back-end needle, so that the vacuum can pull the blood in to the tube.".

• 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
• MDR Report Key: 9355700
• MDR Text Key: 195250184
• Report Number: 1917413-2019-02396
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903648158
• UDI-Public: 50382903648158
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other