MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH® FOLEY CATHETER TRAY

Model Number	A899616
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
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 report that a betadine swab stick from a foley prep kit was left in a patient post surgery.At the start of a surgery, an or nurse was preparing to insert a foley catheter into an obese female patient.The nurse reported difficulty visualizing the urethra.After the nurse prepped the site, she placed one of the betadine prep swabs into the patient's vagina to act as a landmark.The procedure was completed and the patient was discharge home.Post operation day one, the patient call the post operative unit complaining of some vaginal pressure.Then, while she was urinating she pulled a small hard plastic piece out of her vagina.The patient was instructed to go to her physicians office.It was determined that the item removed was a betadine swab stick from a foley prep kit.The patient was not injured.Upon the investigation by the hospital it was discovered that this was a common practice among nurses even though it was not the intended use of the betadine prep swab in the foley kit.The facility wanted to alert the manufacture to consider putting a warning label on package or alter the design of the prep stick to prevent it from being placed in the vagina.
Event or Problem Description
It was report that a betadine swab stick from a foley prep kit was left in a patient post surgery.At the start of a surgery, an or nurse was preparing to insert a foley catheter into an obese female patient.The nurse reported difficulty visualizing the urethra.After the nurse prepped the site, she placed one of the betadine prep swabs into the patient's vagina to act as a landmark.The procedure was completed and the patient was discharge home.Post operation day one, the patient call the post operative unit complaining of some vaginal pressure.Then, while she was urinating she pulled a small hard plastic piece out of her vagina.The patient was instructed to go to her physicians office.It was determined that the item removed was a betadine swab stick from a foley prep kit.The patient was not injured.Upon the investigation by the hospital it was discovered that this was a common practice among nurses even though it was not the intended use of the betadine prep swab in the foley kit.The facility wanted to alert the manufacture to consider putting a warning label on package or alter the design of the prep stick to prevent it from being placed in the vagina.
Additional Manufacturer Narrative
The reported event was confirmed as use of device issue based on event description.No sample was returned for evaluation.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.¿ 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.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH® FOLEY CATHETER TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9233325
• Report Number: 1018233-2019-06745
• Device Sequence Number: 19718164
• Product Code: EZC
• UDI-Device Identifier: 00801741104534
• UDI-Public: (01)00801741104534
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 11/07/2019

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: A899616
• Device Catalogue Number: A899616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1