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

Catalog Number 0035280

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

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 inside of the syringe contained dirt.

Event Description

It was reported that inside of the syringe contained dirt.

Manufacturer Narrative

The reported event was confirmed with an unknown cause.Received 1 unused bulk clean syringe for evaluation.During the visual inspection, it was noted that the bulb had foreign material at the bottom of the bulb.The foreign material was measured to be 4/32 in.In order to verify if the foreign material was embedded, a towel was wet with alcohol and the bulb was wiped with the towel.During this task, the foreign material was removed.The foreign material was found to be loose.However, the foreign material exceeded its specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "irrigation syringe bulb type non sterile" (b)(4).

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7264200
• MDR Text Key: 99944493
• Report Number: 1018233-2018-00419
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1