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

Model Number A319516AM

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the they found a hair in the plunger of gel in foley tray.Per follow up via email on 26 june 2023, it was stated that the customer had the product, taped the hair to the label but it was originally in the syringe of gel.Also stated that it did not affect the patient, it was found prior to use.

Manufacturer Narrative

The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), plunger.Visual inspection of the sample noted a strand of hair was taped to the label.This does not meet specification which states that "no hair on the product is allowed".A potential root cause for this failure mode could be "no follow up to cleaning procedure in the production areas".The device history record review could not be performed without a lot number.The investigation is concluded, and no additional action is required at this time.The instructions for use were found adequate and state the following: ¿surestep foley tray system warning: do not use.If allergic to iodine for urological use only this preconnected closed system foley tray contains: ¿ lubri-sil i.C all-silicone 400-series temperature ¿ sensing anti-microbial foley catheter ¿ statlock foley stabilization device ¿ anti -microbial control ¿ fit outlet device ¿ 350ml urine meter ¿ bacteriostatic drainage tube ¿ bacteriostatic collection bag (2500ml) ¿ 3 foam swabs ¿ povidone-iodine packet ¿ peri-care kit ¿ soap towelettes ¿ hand sanitizer warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.¿ 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the they found a hair in the plunger of gel in foley tray.Per follow up via email on 26jun2023, it was stated that the customer had the product, taped the hair to the label but it was originally in the syringe of gel.Also stated that it did not affect the patient, it was found prior to use.

• 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: 17288718
• MDR Text Key: 319031199
• Report Number: 1018233-2023-05000
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741073892
• UDI-Public: (01)00801741073892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A319516AM
• Device Catalogue Number: A319516AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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