MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; ENDROTRACHEAL

Model Number	35W040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes siliconized cuff overstretches and cannot be blocked.Unknown if any patient adverse events occurred.
Additional Manufacturer Narrative
One used device was returned for evaluation.Visual inspection of the returned device did not reveal any defects.Using a syringe, 10 ml of air was inserted into the inflation system.Only a small portion of the cuff inflated.The instruction for use states under directions to: "attach a syringe to the pilot balloon and inflate the cuff with 5ml of sterile water".If the cuff does not inflate completely, squeeze the pilot balloon while massaging the cuff.If the cuff still does not inflate, use a new tube.Following the directions in (ifu), the pilot balloon was squeezed, which forced the air into the cuff (reference picture).The cuff was deflated and inflated several times without issue.The investigation determined that the device functioned as designed.

• Brand Name: BIVONA
• Common Device Name: ENDROTRACHEAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11852707
• Report Number: 3012307300-2021-04677
• Device Sequence Number: 14240276
• Product Code: BTR
• UDI-Device Identifier: 15021312014303
• UDI-Public: 15021312014303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K792035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 01/17/2025
• Device Model Number: 35W040
• Device Catalogue Number: 35W040
• Device Lot Number: 3889964, 3907911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1