MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367324

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka/fpa.Common device name: blood specimen collection device; intravascular administration set.

Event Description

It was reported when using the bd vacutainer push button blood collection set, the device experienced blood leakage from the tubing of the wingset.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer's report is that blood leaked from the tubing of wingset pbbcs.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced blood leakage from the tubing of the wingset.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer's report is that blood leaked from the tubing of wingset pbbcs.

Manufacturer Narrative

Bd received 1 push button sample and 4 photos for investigation.The photos were reviewed and the indicated failure mode for a leak was observed.Additionally, the customer sample was evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and upon completion, the indicated failure mode for a leak was observed only on the returned sample.A visual inspection of the returned sample revealed evidence of use.Additionally, an evaluation of the retained samples was conducted and the issue of leakage (cut tubing) (leakage) 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 of leakage (cut tubing).Bd determined that the root cause of the indicated failure mode was likely attributed to the tubing being cut during the packaging/sealing process.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15887276
• MDR Text Key: 307686418
• Report Number: 1710034-2022-00731
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673247
• UDI-Public: 00382903673247
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K030573
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 367324
• Device Lot Number: 1351779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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