MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK / CLEAN, 50ML; IRRIGATION SYRINGE

Catalog Number 0935280

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

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

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 were black specs inside the syringes.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.Visual evaluation of the sample noted five opened (without original packaging) irrigation bulb syringes.Of the five syringes, there were two with dark specks on the syringe barrel.One of these syringes had both specks around the 40 cc increment while the other had one speck in the tip ad another towards the middle of the barrel.However, due to the sample being a photo, it cannot be determined if the foreign material is small enough to meet the specification where loose or embedded foreign matter greater than 0.6mm^2 is not permitted per procedure.A potential root cause for this reported failure could be defective / contaminated components from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.21 cfr 801.116 outlines the conditions upon which a device is exempt from adequate directions as follows: "sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." product catalog number 0935280 is deemed by appropriate subject matter experts (sme) to be within this definition.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 were black specs inside the syringes.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9238357
• MDR Text Key: 170478378
• Report Number: 1018233-2019-06798
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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 Catalogue Number: 0935280
• Device Lot Number: NGDT3054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1