MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ SYRINGE TIP CAP; LIQUID MEDICATION DISPENSER

Catalog Number 305819

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/21/2018

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 #: 7200661.Medical device expiration date: 2022-09-30.Device manufacture date: 2017-07-19.Medical device lot #: 8207911.Medical device expiration date: 2023-06-30.Device manufacture date: 2018-07-26.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 with the use of the bd¿ syringe tip cap there were 2 issues with leakage from the seal between the cap and the syringe, once with lot# 7200661 and once with 8207911.

Event Description

It was reported with the use of the bd¿ syringe tip cap there were 2 issues with leakage from the seal between the cap and the syringe, once with lot# 7200661 and once with 8207911.

Manufacturer Narrative

Investigation: ten representative samples were received.They were visually inspected under the microscope.A functional test was performed by connecting them to a saline syringe, the plunger rod of the syringe was pushed down trying to expel the saline solution.No leakage was observed, therefore failure mode is not verified.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD¿ SYRINGE TIP CAP
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8233225
• MDR Text Key: 132623537
• Report Number: 1911916-2018-00834
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305819
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other