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

Model Number	800061
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Urinary Retention (2119); Abdominal Distention (2601); No Known Impact Or Consequence To Patient (2692)
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 drainage bag tubing did not have a hole for the urine to drain into the bag.It appeared that in place of a hole there was solid plastic.The catheter was placed for urine drainage during a cesarean section.It was later reported via email from the complainant on (b)(6) 2018 that the bladder was distended during the procedure and allegedly caused the provider to have some difficulty visualizing parts of the surgical field during the procedure.There was no added time to admission or an adverse outcome.The issue was discovered after the procedure.The bag was removed from the tube and the tube was allowed to drain.The bag was replaced with one from another kit and worked normally.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation noted one used drainage bag with no original packaging present.The opening of the anti-reflux chamber (cm2098) where the inlet tube is inserted was not cut out to allow drainage of urine into the bag.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: ¿proper techniques for urinary catheter insertion ¿ perform hand hygiene immediately before and after insertion ¿ insert urinary catheters using aseptic technique and sterile equipment ¿ use the smallest foley catheter possible, consistent with good drainage ¿ document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance ¿ secure the foley catheter, use the statlock® foley stabilization device if provided ¿ maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions ¿ maintain unobstructed urine flow and keep the catheter and collection tube free from kinking ¿ keep the collection bag below the level of the bladder or hips at all times ¿ empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed ez-lok® sampling port fig.3 fig.2 fig.1a fig.1b sterilized using ethylene oxide.".
Event or Problem Description
It was reported that the drainage bag tubing did not have a hole for the urine to drain into the bag.It appeared that in place of a hole there was solid plastic.The catheter was placed for urine drainage during a cesarean section.It was later reported via email from the complainant on 25-oct-18 that the bladder was distended during the procedure and allegedly caused the provider to have some difficulty visualizing parts of the surgical field during the procedure.There was no added time to admission or an adverse outcome.The issue was discovered after the procedure.The bag was removed from the tube and the tube was allowed to drain.The bag was replaced with one from another kit and worked normally.

• Brand Name: BARD® FOLEY TRAY WITH BARD® HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: BARD LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8069945
• Report Number: 1018233-2018-05356
• Device Sequence Number: 2325482
• Product Code: EZC
• UDI-Device Identifier: 00801741024153
• UDI-Public: (01)00801741024153
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 12/07/2018

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: 800061
• Device Catalogue Number: 800061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1