MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER UROVAC¿ BLADDER EVACUATOR; EVACUATOR, BLADDER, MANUALLY OPERATED

Model Number	M0067301251
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a bladder evacuator device was unpacked on (b)(6) 2018.According to the complainant, during unpacking, the packaging of the device was noted to be damaged.It was noticed that the packaging has a cut.Reportedly, this was not used in a patient.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.No patient complications have been reported due to this event.

• Brand Name: UROVAC¿ BLADDER EVACUATOR
• Common Device Name: EVACUATOR, BLADDER, MANUALLY OPERATED
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7462373
• Report Number: 3005099803-2018-01284
• Device Sequence Number: 1147425
• Product Code: FFD
• UDI-Device Identifier: 08714729033769
• UDI-Public: 08714729033769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: M0067301251
• Device Catalogue Number: 730-125
• Device Lot Number: 20872043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1