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

Catalog Number 367364

Device Problem Packaging Problem (3007)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that before using bd vacutainer® ultratouch¿ push button blood collection set there was a damaged or open unit package/ seal where sterility is compromised.The following was reported by the initial reporter: according to the customer report package was crushed/damaged.

Manufacturer Narrative

Medical device type: jka d.3-common device name: intravascular administration set e.1.Initial reporter facility name: (b)(6) branch clinic h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with additional/corrected information: d.1.Device available for eval: yes.D.1.Returned to manufacturer on: 26-oct-2023.H.6.Investigation summary: bd received 3 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for damaged unit packaging was observed.The customer samples were evaluated by visual examination and the indicated failure mode for damaged unit packaging with the incident lot was observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of damaged unit packaging was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode damaged unit packaging.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that before using bd vacutainer® ultratouch¿ push button blood collection set there was a damaged or open unit package/ seal where sterility is compromised.The following was reported by the initial reporter: according to the customer report package was crushed/damaged.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18075742
• MDR Text Key: 327589546
• Report Number: 1024879-2023-00783
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212724
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367364
• Device Lot Number: 2234344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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