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

Catalog Number 0035280

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

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 the user found foreign material (like a black ink stain) on the bulb irrigation syringe prior to use.Per additional information from the ibc via email 01-mar-2020, there was a black material or mark just between the seal of where the bulb and syringe came together.

Manufacturer Narrative

The reported event was unconfirmed since the device did not fail to meet relevant specifications.Visual evaluation of the returned sample noted one opened (with original packaging), bulb irrigation syringe.Visual inspection of the sample noted multiple (5) brown/black spots between the syringe body and bulb measuring an aggregate 0.30 sq mm.This is within specification per inspection procedure which states, "loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per the dirt estimation chart." a device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the user found foreign material (like a black ink stain) on the bulb irrigation syringe prior to use.Per additional information from the ibc via email 01mar2020, there was a black material or mark just between the seal of where the bulb and syringe came together.

• Brand Name: BULB TYPE IRRIGATION SYRINGE 50ML, PLASTIC STERILE
• Type of Device: BULB IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9866432
• MDR Text Key: 186613775
• Report Number: 1018233-2020-02025
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049255
• UDI-Public: (01)00801741049255
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 0035280
• Device Lot Number: NGDP0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1