MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD; SYRINGE, PISTON

Catalog Number 303310

Device Problems Defective Device (2588); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2021

Event Type  malfunction  

Event Description

A pharmacist in the children's hospital pharmacy was opening a bd 20 ml sterile ll lf syringe.The technicians noticed that there is some sticky like residue in the 20ml bd syringes and when the plunger is pushed back, condensation appears.They checked 15 of the 20 syringes and they all appeared to be the same.Manufacturer response for 20ml syringe, (brand not provided) (per site reporter): (b)(6) made several inquiries and then manufacturer sent a letter closing the investigation by the end of march stating there was no sample for evaluation.In april, (b)(6) inquired with a representative once again and discovered (b)(6) had held up the defective sample delivery because the off-shore bd facility contact person was not available to accept the package.A month later, (b)(6) requested this be escalated within the customer service at bd.In mid-june, bd informed (b)(6) that the product is still in customs and the case will remain closed.They would open the case if the product arrives to bd.Escalated to vendor relations at (b)(6) as we have sequestered product across the entire health system.

• Brand Name: BD
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12057157
• MDR Text Key: 258117333
• Report Number: 12057157
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 303310
• Device Lot Number: 136383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1