MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE

Catalog Number 0035280

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

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that debris was found on the bulb of the syringe.Per sample receipt, it was found that foreign material was inside the syringe as well as on the bulb.

Manufacturer Narrative

The reported issue was confirmed, as cause unknown.During the visual inspection it was noted foreign material in the bulb.That exceeded it's specification.Unable to determine where the sample got the foreign material, since the sample was receive out of it's packaging.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "irrigation syringe bulb type non sterile".(b)(4).

Event Description

It was reported that debris was found on the bulb of the syringe.Per sample receipt, it was found that foreign material was inside the syringe as well as on the bulb.

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: SYRINGE
• 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: 6955476
• MDR Text Key: 89618139
• Report Number: 1018233-2017-05318
• 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: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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