MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 368652

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7185858.Medical device expiration date: 2019-07-31.Device manufacture date: 2017-08-03.Medical device lot #: 7185859.Medical device expiration date: 2019-07-31.Device manufacture date: 2017-08-03.Initial reporter phone#: (b)(6).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 that during use, a bd vacutainer® push button blood collection set was found with ¿cuts in the tubing¿.This resulted in blood leaking out of tubing while performing a blood draw.There was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.A review of the device history record was completed for this batch.Product was manufactured at the bd (b)(4) site july-2017.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.All inspections were in compliance with requirements.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).Capa# (b)(4).

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7125987
• MDR Text Key: 95731769
• Report Number: 1024879-2017-01338
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903686525
• UDI-Public: 50382903686525
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 368652
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• 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
• Patient Outcome(s): Other