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

Model Number	A304416A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	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 the syringe had a large piece of hard plastic debris within the solution.The defect was noticed before being used on the patient.
Event or Problem Description
It was reported that the syringe had a large piece of hard plastic debris within the solution.The defect was noticed before being used on the patient.
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted one syringe and the foley tray labeling were received.Visual evaluation noted the syringe had a large piece of foreign material inside the syringe.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be inspection results (measurement, testing data) not verified by iqa assignee.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed due to the foreign material being a confirmed supplier related event, and the defect occurred before the product arrived at the end user.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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9233543
• Report Number: 1018233-2019-06751
• Device Sequence Number: 2209436
• Product Code: MJC
• UDI-Device Identifier: 00801741104206
• UDI-Public: (01)00801741104206
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: A304416A
• Device Catalogue Number: A304416A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1