MAUDE Adverse Event Report: C. R. BARD, INC. BARD® BULB IRRIGATION SYRINGE; SYRINGE, IRRIGATION

Catalog Number 0035280

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

Ep physician was creating a skin pocket for the insertion a pacemaker.Part of that process is to use a 50 cc bulb-type syringe to irrigate the newly created pocket.As he was completing the final inspection of the pocket, the ep physician noticed a 2 to 2.5 cm long very thin sliver of green plastic or rubber sitting in the bottom of the skin pocket.It appears to be from the bottom edge of the green bulb which sits inside the syringe portion of the bulb-syringe device.When i look through the clear plastic of the syringe portion, i can see that the neck edge of the green bulb it not smooth.Part of the bulb still has a rough edge remaining and attached.It's very apparent that the selvage edge at the neck of the bulb was where the green sliver broke off and the sliver was propelled into the skin pocket during the irrigation process.To my eye, the sliver which broke off seems to be a by product of the manufacturing process.There was no harm to the patient and the sliver was quickly removed.I have both the bulb syringe and the green plastic/rubber sliver which was retrieved in my office.I have already contacted the company rep so they can send me the box to return the items to the company.Manufacturer response for bulb syringe, (brand not provided) (per site reporter): the company rep has agreed to send me a box so i can mail it to them.

• Brand Name: BARD® BULB IRRIGATION SYRINGE
• Type of Device: SYRINGE, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7227207
• MDR Text Key: 98572043
• Report Number: 7227207
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 0035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 85 YR