MAUDE Adverse Event Report: CIRCULATORY TECHNOLOGY, INC THE BIGGER BETTER BLADDER

Model Number	BB14, BBB38
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All better bladder products are visually inspected and tested during manufacturing.Lots 180307 and 190603 were manufactured by contract manufacturer, dg medical, on 3/27/2018 and 6/13/2019, respectively.All units were successfully tested and there were no nonconformities or deviations noted during manufacturing.Testing of the returned units found that the units were fully functional, although cti does acknowledge minor crinkling, which is considered a cosmetic defect.Cti intends to implement corrective actions to minimize crinkling during the manufacturing process and update the ifu to denote that crinkling does not adversely affect the operation of the unit.
Event or Problem Description
The end user reported that two better-bladders had balloons with crinkling and were not usable.They tried to "reinflate" them unsuccessfully.The crinkles are minor and hard to pick up in a photo (do not show well).They became more evident when we put them on 2 different patients and had to remove them emergently.Those were thrown away.Found in our stock 4 bb14 and 2 bbb38.

• Brand Name: THE BIGGER BETTER BLADDER
• Common Device Name: THE BIGGER BETTER BLADDER
• Manufacturer (Section D): CIRCULATORY TECHNOLOGY, INC; 21 singworth street; oyster bay NY 11771
• MDR Report Key: 9373246
• Report Number: 1000522036-2019-00002
• Device Sequence Number: 19451229
• Product Code: DTN
• UDI-Device Identifier: 00851997007004
• UDI-Public: (01)00851997007004(17)5290-U20375(11)190628
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K981284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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: 04/03/2021
• Device Model Number: BB14, BBB38
• Device Catalogue Number: BB14
• Device Lot Number: 5290U20735, 5300T20148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1