MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. NEZHAT-DORSEY TRUMPET VALVE, WITH 5MM 33CM PROBE TIP, AND SUCTION TUBING; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number	5102710
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A request for additional information and the subject product has been made.It is unknown at this time if the sample is available for evaluation.No conclusions can be made at this time.If/when the sample is returned and additional information is received, a supplemental mdr will be submitted.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may of 2018.
Event or Problem Description
It was reported that a customer purchased a case of the nd trumpet valve suction irrigation tubing.After opening the sealed case, one of the packages wasn¿t completely closed and the unit had lost its sterility.

• Brand Name: NEZHAT-DORSEY TRUMPET VALVE, WITH 5MM 33CM PROBE TIP, AND SUCTION TUBING
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7996927
• Report Number: 1213643-2018-03668
• Device Sequence Number: 13799660
• Product Code: HET
• UDI-Device Identifier: 00801741065385
• UDI-Public: (01)00801741065385
• Combination Product (Y/N): N
• PMA/510(K) Number: K913944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

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: Other
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 5102710
• Device Lot Number: JUCRF537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1