MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD BULB IRRIGATION TRAY WITH 2-PIECE 50ML BULB SYRINGE; BULB SYRINGE IRRIGATION TRAY

Catalog Number 750101

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that a black speck was found within the basin.

Manufacturer Narrative

Received 1 bulb irrigation tray with package label.The reported issue was confirmed as cause unknown.Per visual inspection, a loose black particle was found on the tray.No other damages or deficiencies were found.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "note: do not remove bulb from syringe barrel.Sterility of fluid path will be compromised if syringe is disassembled.Open csr wrap to form sterile field.Remove syringe from solution container.Fill container with desired irrigation solution.Place syringe into solution container.Place plastic tray for collection.Disconnect drainage tube from catheter.Fill syringe and irrigate as directed.When irrigation has been completed, reconnect system.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." (b)(4).

Event Description

It was reported that a black speck was found within the basin.

• Brand Name: BARD BULB IRRIGATION TRAY WITH 2-PIECE 50ML BULB SYRINGE
• Type of Device: BULB SYRINGE IRRIGATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 7033306
• MDR Text Key: 92320568
• Report Number: 1018233-2017-05913
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 750101
• Device Lot Number: NGBT2339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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