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

Catalog Number A303416A

Device Problem Short Fill (1575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that when staff opened up the foley tray system, the 10ml sterile water syringe was empty.Also stated that there was no patient harm and could return the product.

Manufacturer Narrative

The reported event was inconclusive, and it is unknown whether the device had met relevant specifications.The product was not used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), syringe.Visual inspection of the sample noted the syringe was empty with no cap attached and we cannot verify if the short fill of the sterile water therefore, this investigation is considered inconclusive.There were no damages observed on the syringe.A potential root cause for this failure mode could be ¿tip cover came off during shipping or in processing.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: "this preconnected closed system foley tray contains: lubri-sil® i.C.Anti-microbial all-silicone foley catheter; statlock® foley stabilization device; anti-microbial control-fit outlet device; 350 ml urine meter; bacteriostatic drainage tube; bacteriostatic collection bag (2500 ml); 3 foam swabs; povidone-iodine packet; peri-care kit; soap towelettes; hand sanitizer.Bard, complete care, control-fit, ez-lok, lubri-sil, statlock and surestep are trademarks and/or registered trademarks of c.R.Bard, inc.*bacti-guard is a registered trademark of bactiguard ab.Bacti-guard® silver alloy coating is licensed from bactiguard ab.Tm ez-lok® needleless urine sample port ; lubricating jelly syringe; 10cc syringe of sterile water ; underpad ; fenestrated drape ; gloves | string hanger ; sheeting clip ; specimen container with label intended for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally consult instructions sterilized." h11: section a through f - the information provided by bd represents all 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.The actual/suspected device was inspected.

Event Description

It was reported that when staff opened up the foley tray system, the 10ml sterile water syringe was empty.Also stated that there was no patient harm and could return the product.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17116713
• MDR Text Key: 317338132
• Report Number: 1018233-2023-04261
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: A303416A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other