MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®

Model Number	A303314A
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that a 14f foley kit was opened up and the saline 10 ml syringe only had 2 ml in it.Per additional information received on 04oct2019, the syringe had a cap in place and there was no indication of liquid in the tray or on any other tray components.The tray was not used.A second new tray was obtained and used for the patient with no issues.
Event or Problem Description
It was reported that a 14f foley kit was opened up and the saline 10 ml syringe only had 2 ml in it.Per additional information received on 04oct2019, the syringe had a cap in place and there was no indication of liquid in the tray or on any other tray components.The tray was not used.A second new tray was obtained and used for the patient with no issues.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), water-filled 10cc syringe.Visual inspection of the sample noted the cap was missing from the sample and there was only trace liquid remaining in the syringe.This is out of specification per inspection procedure, which states, "water fill volume: 9.6 + 0.4/-0.6cc" and "syringe tip must have a cap attached." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿tip cover came off during shipping or in processing.¿ 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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9194258
• Report Number: 1018233-2019-06513
• Device Sequence Number: 2159342
• Product Code: MJC
• UDI-Device Identifier: 00801741073786
• UDI-Public: (01)00801741073786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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
• Operator of Device: Health Professional
• Device Model Number: A303314A
• Device Catalogue Number: A303314A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1