MAUDE Adverse Event Report: FREUDENBERG MEDICAL, LLC BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

Model Number	BE 6055
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a review of the maude database on 11/22/2019, two user reports were discovered concerning a total of 2 of inhealth's tracheoesophageal puncture sets.Freudenberg medical had not been made aware of these events prior to the maude review.Both reports read as follows: "an (b)(6) male.During procedure a piece of the plastic sheath broke off inside the patient.Piece was successfully retrieved and removed from the patient.A second sheath was attempted and also started to tear, but did not break off.Second sheath removed.Fda safety report id # (b)(4)." freudenberg medical does not have any contact information to facilitate a follow-up with the reporter.

• Brand Name: BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
• Common Device Name: TRACHEOESOPHAGEAL PUNCTURE SET
• Manufacturer (Section D): FREUDENBERG MEDICAL, LLC; 1110 mark ave; carpinteria CA 93013
• MDR Report Key: 9501047
• Report Number: 2025182-2019-00003
• Device Sequence Number: 11088854
• Product Code: EWL
• UDI-Device Identifier: 00813307013068
• UDI-Public: (01)00813307013068(17)211128(10)0000099350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K920090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 11/28/2021
• Device Model Number: BE 6055
• Device Catalogue Number: BE 6055
• Device Lot Number: 0000099350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/20/2019
• 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: Required Intervention