MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PROXIS¿ URETERAL ACCESS SHEATH

Catalog Number	231235
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
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.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that upon opening the package, it was discovered that the tip, end point of the proxis was cracked.The use of the product was not approved due to the possibility of damage to the mucous membranes during insertion.
Event or Problem Description
It was reported that upon opening the package, it was discovered that the tip, end point of the proxis was cracked.The use of the product was not approved due to the possibility of damage to the mucous membranes during insertion.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation noted the sample was provided in a large ziploc bag with no original packaging.Visual requirements states to use unaided eye at 12" to 18" distance under normal room lighting.Section 3.1.1.2 states tube must be free from lumps, voids, ribs, and other deformations.Upon evaluation of the sample, it was observed that there may be a split at the end of the sheath.This split exhibits characteristics akin to those typically associated with material being cut using a blade.Also received 4 photo samples.First photo sample shows top front view of tip and shaft with no obstructions present.Second photo sample shows side profile of dilator with cut present.Third photo sample shows a top view of shaft and dilator side by side.Fourth photo sample zooms in on tip of dilator and shaft.Based on photo and physical sample received the reported event was confirmed cause unknown.No additional actions were required at this time since root cause was not identified.A dhr review did not show any problems or conditions that would have contributed to the reported event.A labelling review was not required as labelling would not have prevented the reported event.Udi format updated with available product information per gudid.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.

• Brand Name: PROXIS¿ URETERAL ACCESS SHEATH
• Common Device Name: URETERAL ACCESS SHEATH
• 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: 20038817
• Report Number: 1018233-2024-05096
• Device Sequence Number: 6537135
• Product Code: FED
• UDI-Device Identifier: 00801741101717
• UDI-Public: (01)00801741101717(11)230906(17)260828(10)BMHVFM19
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 08/28/2026
• Device Catalogue Number: 231235
• Device Lot Number: BMHVFM19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown