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

Model Number	303416A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 syringe used to inject fluid into the valve was found uncapped and leaking in the tray.The kit was discarded except for the syringe.The cap was replaced and sent to risk management.
Event or Problem Description
It was reported that the syringe used to inject fluid into the valve was found uncapped and leaking in the tray.The kit was discarded except for the syringe.The cap was replaced and sent to risk management.It was later reported on (b)(6) 2019 from the complainant, the loose cap from the inflation syringe in the foley tray was placed on the syringe, then sent to risk management.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (with original packaging), aspirate 10cc syringe with an affixed cap.Visual inspection of the sample noted that although the cap was on the syringe tip, the syringe was devoid of most of its liquid content.Only residual liquid droplets remained in the syringe.This is out of specification per inspection procedure which states, "water fill volume: 9.6 + 0.4/-0.6cc." as only residual liquid remained in the syringe, the fill volume was significantly below specification.Additionally, it is unknown whether the cap returned with the sample was the original cap or a replacement cap from another product.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿tip cover came off during shipping or in processing.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the syringe used to inject fluid into the valve was found uncapped and leaking in the tray.The kit was discarded except for the syringe.The cap was replaced and sent to risk management.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (with original packaging), aspirate 10cc syringe with an affixed cap.Visual inspection of the sample noted that although the cap was on the syringe tip, the syringe was devoid of most of its liquid content.Only residual liquid droplets remained in the syringe.This is out of specification per inspection procedure which states, "water fill volume: 9.6 + 0.4/-0.6cc." as only residual liquid remained in the syringe, the fill volume was significantly below specification.Additionally, it is unknown whether the cap returned with the sample was the original cap or a replacement cap from another product.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿tip cover came off during shipping or in processing.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9117650
• Report Number: 1018233-2019-05932
• Device Sequence Number: 468494
• Product Code: EZL
• UDI-Device Identifier: 00801741024726
• UDI-Public: (01)00801741024726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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,Followup
• Report Date (Section B): 10/16/2019

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 Expiration Date: 09/30/2021
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGDQ2739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/14/2019; 10/14/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/03/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1