MAUDE Adverse Event Report: C.R. BARD INC. EAR AND ULCER SYRINGE; SYRINGE, IRRIGATING (NON-DENTAL)

Model Number 0035830

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2018

Event Type  malfunction  

Event Description

This was a case for a breast lumpectomy.The bulb syringe (ear and ulcer syringe) was opened during the case and a small piece of green plastic matching the green plastic of the bulb came out of it when it was being used to irrigate.The piece was removed from the surgical field.

• Brand Name: EAR AND ULCER SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON-DENTAL)
• Manufacturer (Section D): C.R. BARD INC. ; covington GA 30014
• MDR Report Key: 7373196
• MDR Text Key: 103699291
• Report Number: MW5076153
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 0035830
• Device Lot Number: NGBU0223
• 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: 56 YR