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

Catalog Number 0035280

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2019

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 there was foreign material inside of the syringe.

Manufacturer Narrative

The reported event was confirmed as cause unknown.Although the reported event was confirmed, a root cause could not be determined.The inspector received one open irrigation syringe with the original packaging.Foreign material was noted to be inside of the syringe and noted to be reddish in color.Per specification, "loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per the dirt estimation chart." foreign material was measured to be 3.00 mm^2.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (usa) law restricts this device to sale by or on the order of a physician." 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 there was foreign material inside of the syringe.

• 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: 8475746
• MDR Text Key: 140884617
• Report Number: 1018233-2019-01660
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 0035280
• Device Lot Number: NGCV4128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1