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

Model Number	BB14
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the complainant called and informed cti that an additional unit from lot 5290-210401 failed the required leak test prior to use.This unit was not used on a patient.
Additional Manufacturer Narrative
This event was initially reported in a summary report on 5/26/2021.It is now being submitted as an individual report.All better bladder units are visually inspected and tested during manufacturing prior to release.Testing includes a pull test and leak testing to verify a hermetic seal.The units met all acceptance criteria.Evaluation of retain samples confirmed the product complaint.The units were found to have insufficient adhesive applied during the assembly resulting in an ineffective seal between the pigtail and the housing port.At the time of this report, this issue has been detected in two manufacturing lots, lot 5290-201001 and 5290-210401.Both lots have been recalled.Root cause: insufficient adhesive.Correction/containment: recall and replace.Corrective actions: an additional step is being incorporated into the assembly of the bb14 and bbb38.Henceforth, additional adhesive will be applied to the external juncture between the pigtail and the housing port, the adhesive to cover at least 1/8" along the entire periphery of the external wall of housing and at least 1/8" along the entire periphery of the od of the pigtail.This enhancement would assure more adhesive, a post assembly visual observation of the adhesive and the additional sealing that has proved effective for the seal between the large tube and the housing, a seal that has that bead.Preventive actions: add pull gage with force requirement to the process specification.Add an in-process and finished product visual inspection of the glue bead around the pigtail.There have been no issues report since implementation of corrective action.

• Brand Name: THE BETTER BLADDER
• Common Device Name: BETTER BLADDER
• Manufacturer (Section D): CIRCULATORY TECHNOLOGY, INC.; 21 singworth st; oyster bay NY 11771
• MDR Report Key: 12647246
• Report Number: 1000522036-2021-00005
• Device Sequence Number: 1454065
• Product Code: DTN
• UDI-Device Identifier: 00851997007004
• UDI-Public: (01)00851997007004(10)5290210401(17)20240401(11)20210401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K981284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall,Replace
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 04/01/2024
• Device Model Number: BB14
• Device Catalogue Number: BB14
• Device Lot Number: 5290-210401
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other