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

Catalog Number 0035280

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 Date 05/26/2020

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 foreign material was found in the syringe.

Event Description

It was reported that foreign material was found in the syringe.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (no original packaging), unused irrigation bulb syringe.It was noted that there was 6 black particles on the outside surface of the syringe barrel, with 3 foreign materials at 0.05 sq mm, 2 at 0.10 sq mm and 1 at 0.40 sq.Mm.This does not meet the specification as loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this 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.Labeling review was not performed because labeling could not have prevented the reported failure.

• 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: 10175472
• MDR Text Key: 196425251
• Report Number: 1018233-2020-03977
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 09/03/2020

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 Catalogue Number: 0035280
• Device Lot Number: NGDV0397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1