MAUDE Adverse Event Report: WELCH ALLYN, INC. KLEENSPEC 590 PREMIUM VAG SPEC MD CASE; SPECULUM, VAGINAL, NONMETAL

Model Number 59001

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Welch allyn/hillrom is reporting this event in an abundance of caution.The actual vaginal speculum was not returned to welch allyn.This device is a manually inserted, disposable vaginal speculum.The root cause of these very rare failures was determined to likely be related to potential impacts or loads on the shipping containers during transit or storage.Based on this information, no further action is required and no further investigation will be performed.

Event Description

Hillrom received a report from a the account that the vaginal speculum broke inside of a patient during a routine exam.There was no serious patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: KLEENSPEC 590 PREMIUM VAG SPEC MD CASE
• Type of Device: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12196105
• MDR Text Key: 264403979
• Report Number: 1316463-2021-00026
• Device Sequence Number: 1
• Product Code: HIB
• UDI-Device Identifier: 00732094143676
• UDI-Public: 732094143676
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 59001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1