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

Catalog Number	0035280
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: BULB IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9866432
• Report Number: 1018233-2020-02025
• Device Sequence Number: 2596255
• Product Code: KYZ
• UDI-Device Identifier: 00801741049255
• UDI-Public: (01)00801741049255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/01/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1