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

Catalog Number 0935280

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

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 a foreign object was found in the irrigation bulb.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the photo sample noted one opened (no original packaging), irrigation bulb syringe.It was noted that the syringe seemed to have a white band on it that was likely added by the user and a small greenish foreign material within the barrel, close to the tip.Although the foreign material could not be measured, as this was a photo sample, the foreign material size seemed to both greatly exceed an area of 0.6 sq mm and exceed a length of 1/16" and did not meet the specification "loose or embedded foreign matter greater than 0.6mm2 or 1/16¿ in length was not permitted.(3 particles maximum per side or surface).Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be no follow up to the production areas cleaning procedure.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.

Event Description

It was reported that a foreign object was found in the irrigation bulb.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: SYRRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9681344
• MDR Text Key: 183915254
• Report Number: 1018233-2020-00855
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0935280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1