MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MINOR PACK - BULB SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number DYNJ49355

Device Problems Contamination /Decontamination Problem (2895); Physical Resistance/Sticking (4012)

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

Event Date 07/30/2019

Event Type  malfunction  

Event Description

Styrofoam from tray of minor pack sticking to bulb portion of bulb syringe.Potential for retained foreign body (styrofoam) if not caught by operating room staff.Fda safety report id# (b)(4).

• Brand Name: MINOR PACK - BULB SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; west reading PA 19611
• MDR Report Key: 8907211
• MDR Text Key: 154957056
• Report Number: MW5089139
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DYNJ49355
• Device Catalogue Number: DYNJ49355
• Device Lot Number: 19EBM388
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR