MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SAFETY-FLOW¿ FOLEY CATHETER TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER; FOLEY TRAY

Model Number	907716
Health Effect - Clinical Codes	Itching Sensation (1943); Laceration(s) (1946); Tingling (2171); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the nurse had a latex reaction while handling the contents of the tray.The nurse reportedly went to urgent care and was released the same day.Per additional information received from the director at the complainant's facility via phone on 11 jun 2019, the nurse was experiencing an itching sensation on the hand which resulted in scratched.The nurse also reportedly had a tingling sensation on the lips.The nurse reportedly received benadryl and solu-medrol injections along with a prednisone prescription.
Event or Problem Description
It was reported that the nurse had a latex reaction while handling the contents of the tray.The nurse reportedly went to urgent care and was released the same day.Per additional information received from the director at the complainant's facility via phone on 11jun2019, the nurse was experiencing an itching sensation on the had which resulted in scratched.The nurse also reportedly had a tingling sensation on the lips.The nurse reportedly received benadryl and solu-medrol injections along with a prednisone prescription.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause for this failure could be "inadequate biological evaluation" and the potential failure mode "bio-compatible".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: "contents: 5cc hydrophilic-coated foley catheter.2000ml (approx.Vol.) capacity center entry.Drainage bag with anti-reflux chamber.Bard® ez-lok® sampling port.String hanger.Attached sheeting clip.Tamper-evident seal.Bard® safety-flowtm outlet device.Uro-preptm tray with: catheter lubricating jelly syringe.Latex-free, powder-free gloves (2).Underpad (waterproof), drape.Forceps, prep balls (5).Povidone-iodine solution.10cc syringe (prefilled with sterile water) to inflate foley catheter only.Specimen container, cap and label.Sterile: contents of inner wrap are sterile unless package has been opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.".

• Brand Name: BARD® SAFETY-FLOW¿ FOLEY CATHETER TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8716831
• Report Number: 1018233-2019-03238
• Device Sequence Number: 2212207
• Product Code: EZC
• UDI-Device Identifier: 00801741024184
• UDI-Public: (01)00801741024184
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 907716
• Device Catalogue Number: 907716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention