MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER INSERTION TRAY; FOLEY TRAY

Model Number	802030
Health Effect - Clinical Codes	Itching Sensation (1943); Respiratory Distress (2045); Shaking/Tremors (2515)
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 information provided by bard 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 bard.The device was not returned.
Event or Problem Description
It was reported that the cma experienced itching and shaky hands, as well as shortness of breath after using the gloves in the foley tray.It was reported that the cma was given over-the-counter benadryl and sent to the er.The cma received an updraft nebulizer treatment, intramuscular injections of prednisone and benadryl, and pepcid by mouth in the emergency department to treat the systemic response.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿bardia foley catheter insertion tray for 30cc balloon contents: ¿ povidone-iodine swabs ¿ waterproof underpad ¿ drape ¿ 30cc syringe (prefilled with sterile water) ¿ gloves ¿ lubricant ¿ graduated collection container single use only.Do not resterilize.For urological use only.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: contents of tray are sterile unless package is opened or damaged, except for povidone-iodine swabs which are not terminally sterilized.1.Remove tray lid.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Open lubricant.Lubricate catheter.6.Open packet of swabs.7.Prep patient with swabs.8.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water.9.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Warning: after use, the product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.".
Event or Problem Description
It was reported that the cma experienced itching and shaky hands, as well as shortness of breath after using the gloves in the foley tray.It was reported that the cma was given over-the-counter benadryl and sent to the er.The cma received an updraft nebulizer treatment, intramuscular injections of prednisone and benadryl, and pepcid by mouth in the emergency department to treat the systemic response.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7512227
• Report Number: 1018233-2018-01706
• Device Sequence Number: 10821281
• Product Code: OHR
• UDI-Device Identifier: 00801741018299
• UDI-Public: (01)00801741018299
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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 Expiration Date: 02/28/2021
• Device Model Number: 802030
• Device Catalogue Number: 802030
• Device Lot Number: NGCN2151
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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