MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COMPLETE CARE FOLEY TRAY; COMPONENT (SYRINGE)

Catalog Number 900014A

Device Problems Short Fill (1575); Defective Component (2292)

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

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that there is only 9cc of water in syringe upon opening the package.The device including the syringe was used.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned and unable to determine root cause of reported problem.The potential root cause for this failure mode could be defective component from supplier.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "2.Accessories closed drainage bag (the illustration shows one example of typical configurations.) syringe prefilled with sterile water water soluble lubricant antiseptics: bard® 10% povidone-iodine solution tweezers gauze pads waterproof sheet cotton balls gloves" 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.H3 other text : the device was not returned.

Event Description

It was reported that there was only 9cc of water in syringe upon opening the package.The device including the syringe was used.

• Brand Name: BARDEX I.C. COMPLETE CARE FOLEY TRAY
• Type of Device: COMPONENT (SYRINGE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10029293
• MDR Text Key: 190496620
• Report Number: 1018233-2020-03070
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900014A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1